Source: http://patents.com/us-9522191.html
Timestamp: 2019-04-25 02:14:57+00:00

Document:
4752470 June 1988 Mehta et al.
5156850 October 1992 Wong et al.
5186930 February 1993 Kogan et al.
5374659 December 1994 Gowan, Jr.
5980088 November 1999 Iwasaki et al.
6419954 July 2002 Chu et al.
7906145 March 2011 Castan et al.
8563033 October 2013 Mehta et al.
2003/0099711 May 2003 Meadows et al.
2004/0131680 July 2004 Goldenheim et al.
2005/0019393 January 2005 Augsburger et al.
2005/0142097 June 2005 Thassu et al.
2011/0117205 May 2011 Castan et al.
US 7,431,994, 10/2008, Mehta (withdrawn) cited by applicant .
Mehta, U.S. Appl. No. 14/554,123, filed Nov. 26, 2014, cited by applicant .
Tris Pharma, Inc. v. Par Pharmaceutical, Inc. et al., Complaint, US District Court for the District of Delaware, C.A. No. 15-0068 (GMS), Jan. 21, 2015. cited by applicant .
Tris Pharma, Inc. v. Par Pharmaceutical, Inc. et al., Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Answer to Complaint and Counterclaims, US District Court for the District of Delaware, Feb. 12, 2015. cited by applicant .
Tris Pharma, Inc. v. Par Pharmaceutical, Inc. et al., Answer to Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Counterclaims, US District Court for the District of Delaware, Feb. 26, 2015. cited by applicant .
Biederman, "New Generation Long-Acting Stimulants for the Treatment of Attention-Deficit/Hyperactivity Disorder", Medscape Psychiatry, vol. 8(2), Nov. 2003. cited by applicant .
Cascade et al., "Short-Acting Versus Long-Acting Medications for the Treatment of ADHD", Psychiatry, vol. 5(8):24-27, Aug. 2008. cited by applicant .
Chavez et al., "An Update on Central Nervous System Stimulant Formulations in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder", The Annals of Pharmacotherapy, vol. 43(6):1084-1095, Jun. 2009. cited by applicant .
Concerta.RTM., Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-121, Center for Drug Evaluation and Research, Jun. 2000. cited by applicant .
Concerta.RTM., Medical Reviews, App. No. 21-121, Center for Drug Evaluation and Research, Jul. 1999 (completed Mar. 2000). cited by applicant .
Connors et al., Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists (2.sup.nd Ed.), John Wiley & Sons, pp. 587-589., Jan. 1986. cited by applicant .
Daughton et al., "Review of ADHD Pharmacotherapies: Advantages, Disadvantages, and Clinical Pearls", J. Am. Acad. Child and Adolescent Psychiatry, vol. 48(3):240-248, Mar. 2009. cited by applicant .
Daytrana.RTM., Clinical Pharamacology and Biopharmaceutics Reviews, App. No. 21-514, Center for Drug Evaluation and Research, Jun. 2005. cited by applicant .
Daytrana.RTM., Medical Reviews, App. No. 21-514, Center for Drug Evaluation and Research, Feb. 2006. cited by applicant .
Ermer et al., "Pharmacokinetic Variability of Long-Acting Stimulants in the Treatment of Children and Adults with Attention-Deficit/Hyperactivity Disorder", CNS Drugs, vol. 24(12):1009-1025, Dec. 2010. cited by applicant .
Flynn, "Buffers--pH Control within Pharmaceutical Systems", J. Parenteral Drug Association, vol. 34(2):139-162, Mar. 1980. cited by applicant .
Focalin.RTM. XR, Clinical Pharamacology and Biopharmaceutics Reviews, App. No. 21-802, Center for Drug Evaluation and Research, Jul. 2004. cited by applicant .
Focalin.RTM. XR, Medical Review, App. No. 21-802, Center for Drug Evaluation and Research, Jul. 2004. cited by applicant .
Ghuman et al., "Psychopharmacological and Other Treatments in Preschool Children with Attention Deficit/Hyperactivity Disorder: Current Evidence and Practice", J. Child and Adolescent Psychopharmacology, vol. 18(5):413-447, Oct. 2008. cited by applicant .
Gonzales et al., "Methylphenidate Bioavailability from Two Extended-Release Formulations", Int'l J. Clinical Pharmacology and Thereapeutics, vol. 40(4):175-184, Apr. 2002. cited by applicant .
Kulshreshtha et al. (Eds.), Pharmaceutical Suspensions: From Formulation Development to Manufacturing, Springer Science & Business Media, Jan. 2009. cited by applicant .
Metadate CD.RTM., Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-259, Center for Drug Evaluation and Research, Mar. 2001. cited by applicant .
Metadate CD.RTM., Medical Reviews, App. No. 21-259, Center for Drug Evaluation and Research, Mar. 2000. cited by applicant .
Methylin.RTM. ER, Approval Letter and Reviews, App. No. 75-629, Center for Drug Evaluation and Research, May 2000. cited by applicant .
Methylin.RTM. Oral Solution, Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-419, Center for Drug Evaluation and Research, Jul. 2001. cited by applicant .
Methylin.RTM. Oral Solution, Chemistry Reviews, App. No. 21-419, Center for Drug Evaluation Research, May 2002. cited by applicant .
Methylin.RTM. Oral Solution, Medical Reviews, App. No. 21-419, Center for Drug Evaluation and Research, May 2002. cited by applicant .
Patrick et al., "Evolution of Stimulants to Treat ADHD: Transdermal Methylphenidate", Human Psychopharmacology, vol. 24(1):Jan. 1-17, 2009. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Ritalin.RTM. LA", pp. 3104-3106, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Concerta.RTM.", pp. 2598-2504, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Daytrana.RTM.", pp. 3283-3289, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Focalin.RTM." XR, pp. 2472-2477, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Metadate CD.RTM.", pp. 3439-3443, Jan. 2010. cited by applicant .
The Physicians' Desk Reference (60.sup.th ed.), "Tussionex.RTM.", pp. 3443-3444, Jan. 2010. cited by applicant .
The Physicians' Desk Reference for Non-Prescription Drugs, Dietary Supplements, and Herbs (29.sup.th Ed.), "Delsym.RTM.", pp. 602-603, Jan. 2008. cited by applicant .
Greenhill et al., "Practice Parameter for the Use of Stimulant Medications in the Treatment of Children, Adolescents, and Adults", J. Am. Acad. Child and Adolescent Psychiatry, vol. 41(2):26S-49S (supplement), Feb. 2002. cited by applicant .
Prince, "Pharmacotherapy of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Update on New Stimulant Preparations, Atomoxetine, and Novel Treatments", Child and Adolescent Psychiatric Clin N. Am., vol. 15:13-50, Jan. 2006. cited by applicant .
Remington, "The Science and Practice of Pharmacy (20.sup.th Ed)", pp. 986-994, Jan. 2000. cited by applicant .
Ritalin LA.RTM., Clinical Pharmacology and Biopharmaceutics Reviews, App. No. 21-284, Center for Drug Evaluation and Research, Dec. 2001. cited by applicant .
Ritalin LA.RTM., Medical Review(s), App. No. 21-284, Center for Drug Evaluation and Research, Nov. 2000. cited by applicant .
Swanson et al., "Comparison of Once-Daily Extended Release methylphenidate Formulations in Children With Attention-Deficit/Hyperactivity Disorder in the Laboratory School (The Comacs Study)", Pediatrics, vol. 113(3):206-16, Mar. 2004. cited by applicant .
The Pharmacopeia of the United States (25.sup.th revision), "Pharmaceutical Dosage Forms", pp. 2213-2225, Nov. 2001. cited by applicant .
Wigal et al., "Selection of the Optimal Dose Ratio for a Controlled-Delivery Formulation of Methylphenidate", J. Appl. Research., vol. 3:46-63, Oct. 2003. cited by applicant .
Codeprex.RTM., Product Label, marketed by UCB, Inc., Jun. 21, 2004. cited by applicant .
Methylin.RTM. Oral Solution, Product Label, marketed by Mallinckrodt Inc., May 2006. cited by applicant .
Methylin.RTM. ER, Product Label, marketed by Mallinckrodt Inc., Oct. 2013. cited by applicant .
Notice of Paragraph IV Certification from Par Pharmaceuticals, dated Apr. 2, 2015, and "Detailed Statement of the Factual and Legal Bases for Par's Opinion that U.S. Pat. No. 8,956,649 is Invalid, Unenforceable, and/or Will Not Be Infringed." cited by applicant .
Notice of Paragraph IV Certification from Par Pharmaceuticals, dated Jun. 17, 2015, and "Detailed Statement of the Factual and Legal Bases for Par's Opinion that U.S. Pat. No. 9,040,083 is Invalid, Unenforceable, and/or Will Not Be Infringed." cited by applicant .
Complaint by Tris Pharma, Inc. against Actavis Laboratories FL, Inc. et al., C.A. No. 14/1309-GMS, dated Oct. 15, 2014. cited by applicant .
Defendant Actavis Laboratories FL, Inc.'s Answer, Defenses, and Counterclaims, C.A. No. 14/1309-GMS, dated Dec. 5, 2015. cited by applicant .
Answer to Actavis Laboratories FL, Inc.'s Counterclaims, C.A. No. 14/1309-GMS, dated Dec. 29, 2014. cited by applicant .
First Amended Complaint, C.A. No. 14/1309-GMS, dated May 22, 2015. cited by applicant .
Defendant Actavis Laboratories FL, Inc.'s Initial Invalidity Contentions, C.A. No. 14-1309-GMS, dated May 27, 2015. cited by applicant .
Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Initial Invalidity Contentions, C.A. No. 14/1309-GMS, dated Jun. 10, 2015. cited by applicant .
Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Answer to First Amended Complaint and Counterclaims, dated Jun. 12, 2015. cited by applicant .
Complaint by Tris Pharma, Inc. against Actavis Laboratories FL, Inc., et al., C.A. No. 15-393-GMS, dated May 15, 2015. cited by applicant .
Defendant Actavis Laboratories FL, Inc.'s Answer, Affirmative Defenses, and Counterclaims, C.A. No. 15-393-GMS, dated Jun. 12, 2015. cited by applicant .
Defendants Par Pharmaceutical, Inc.'s and Par Pharmaceutical Companies, Inc.'s Answer to Second Amended Complaint and Counterclaims, C.A. No. 14/1309-GMS, dated Aug. 24, 2015. cited by applicant .
Notice of Paragraph IV Certification from Actavis, dated Spetember 9, 2015, and "Actavis's Detailed Factual and Legal Bases for Its Paragraph IV Certification that U.S. Pat. No. 9,040,083 is Invalid, Unenforceable and/or Not Infringed." cited by applicant .
IndustrialSpec.com, Mesh & Micron Sizes: Mesh to Micron Conversion Chart, p. 1, Aug. 27, 2015. cited by applicant .
Notice of Allowance with Interview Summary issued on related U.S. Appl. No. 14/735,526, dated Oct. 13, 2015. cited by applicant .
Response to Office Action dated Aug. 27, 2015, issued on related U.S. Appl. No. 14/735,526, dated Sep. 21, 2015. cited by applicant .
Non-final Office Action issued on related U.S. Appl. No. 14/735,526, dated Aug. 27, 2015. cited by applicant .
Tris Pharma Inc. vs. Actavis Laboratories., et al. Defendant Actavis Laboratories FL, Inc.'s Amended Initial Invalidity Contentions, C.A. No. 14/1309-GMS (consolidated), pp. 1-198, Jan. 22, 2016. cited by applicant .
Tris Pharma Inc. vs. Actavis Laboratories., et al. Defendant Actavis Laboratories FL, Inc.'s Final Initial Invalidity Contentions, C.A. No. 14/1309-GMS (consolidated), pp. 1-203, Feb. 8, 2016. cited by applicant .
Active Ingredients, Ion Exchange Resins-Healthcare, Rohm Haas, pp. 1, www.F:/Heathcare.sub.--Website/deliquescence.htm (Feb. 9, 2006). cited by applicant .
Amberlite IRP and Duolite AP143 Applications Reference List, Rohm Haas Ion Exchange Resins-Healthcare, www.rohrnhaas.com (Dec. 1, 2004). cited by applicant .
Amberlite IRP and Duolite AP143 Ion Exchange Resins Bulk Pharmaceutical Chemicals for Finished Dosage Forms, pp. 1-2, Healthcare Website/release.sub.--refl.htm (Feb. 2, 2006). cited by applicant .
Amberlite IRP and Duolite, AP Ion Exchange Resins, Ion Exchange Resins-Healthcare, Rohm Haas, pp. 1, www.F:/Heathcare.sub.--Website/formulations.sub.--products.htm (Feb. 9, 2006). cited by applicant .
Amberlite IRP64 Pharmaceutical Grade Cation Exchange Resin, Product Data Sheet, pp. 1-3 (Sep. 2004). cited by applicant .
Amberlite IRP69 Pharmaceutical Grade, 54OES (Feb. 2006). cited by applicant .
Amberlite IRP69 Phamaceutical Grade Cation Exchange Resin, Product Data Sheet, pp. 1-4 (Nov. 2004). cited by applicant .
Amberlite IRP88 Pharmaceutical Grade Cation Exchange Resin, Product Data Sheet, pp. 1-4 (Nov. 2004). cited by applicant .
Quadir, Release Characteristics . . . of selected drugs with a newly developed polyvinyl acetate dispersion, ExAct, 13:4 (Dec. 2004). cited by applicant .
Andrist, Comparative Psychotomimetic Effects of Stereoisomers of Amphetamine, Nature, 234:152-153 (Nov. 19, 1971). cited by applicant .
Arnold, Levoamphetamine and Dextroamphetamine: Comparative Efficacy in the Hyperkinetic Syndrome, Archives of General Psychiatry, 27:816-822 (Dec. 1972). cited by applicant .
Aoyama, Pharmacodynamic Modeling for Change of Locomotor Activity by Methylphenidate in Rats, Pharmaceutical Research, 14(11):1601-1606 (Nov. 1997). cited by applicant .
BASF Aktiengesellschaft, Contents, Introduction, pp. 1-13, 2004. cited by applicant .
BASF, A New Sustained Release Excipient, ExAct, 3: 2 (Nov. 1999). cited by applicant .
BASF Pharma Solutions: Excipients by Trademark, Kollicoat.RTM., BASF website, www.pharma-solutions.basf.com, pp. 1-3 (Dec. 2, 2004). cited by applicant .
BASF, Pharmasolutions, Men/PD 130, Correlation of Drug Prevention Through Isolated Films and Coated Dosage forms Based on Kollicoat 30SR, 1999. cited by applicant .
BASF, Development of High Functionality Excipients for Immunity and Sustained Release Dos Forms (Sep. 20, 2004). cited by applicant .
BASF, Product Catalog (2008). cited by applicant .
BASF--Expertise in Health and Nutrition, Sustained Release Excipients, p. 1-13, Kollicoat.RTM. SR 30 D, Tackiness of Films as a Function of Type and Concentration of Plasticizer (2007). cited by applicant .
Bordawekar, Evaluation of Polyvinyl Acetate Dispersion as a Sustained Release Polymer for Tablets, Drug Delivery, 13(2):121-131 (Mar. and Apr. 2006). cited by applicant .
Bordawekar, Evaluation of Kollicoat.RTM. SR 30D as a Sustained Release Polymer Dispersion, BASF Corporation, University of Rhode Island, p. 25, AAPS Poster (2002). cited by applicant .
Borodkin, Polycarboxylic Avid Ion-Exchange Resin Adsorbates for Taste Coverage in Chewable Tablets, Journal of Pharmaceutical Science 60(10):1523-1527 (Oct. 1971). cited by applicant .
Childress, The Single-Dose Pharmacokinetics of NWP06, a Novel Extended-Release Methylphenidate Oral Suspension, Postgraduate Medicine, 122(5):35-41 (Sep. 2010). cited by applicant .
Dashevsky, Compression of Pellets Coated with Various Aqueous Polymer Dispersions, International Journal of Pharmaceutics, 279(1-2):19-26 (Jul. 26, 2004). cited by applicant .
Dashevsky, Physicochemical and Release Properties of Pellets Coated with Kollicoat SR 30 D, a New Aqueous Polyvinyl Acetate Dispersion for Extended Release, International Journal of Pharmaceutics, 290(1-2):15-23 (Feb. 16, 2005; E-publication: Jan. 6, 2005). cited by applicant .
Degussa, Creating Essentials, Specifications and Test Methods for EUDRAGIT.RTM. NE 30 D, p. 1-4 (Sep. 2004). cited by applicant .
Deliquescent Drugs, Ion Exchange Resins-Healthcare, Rohm Haas, pp. 1, www.F:/Heathcare.sub.--Website/deliquescence.htm (Feb. 9, 2006). cited by applicant .
Dissolution Enhancement of Poorly Soluble Drugs, Rohm Haas Ion Exchange Resins-Healthcare, pp. 1, www.rohmhaas.com (Dec. 1, 2004). cited by applicant .
Draganoiu, Evaluation of the New Polyvinylacetate/Povidone Excipient for Matrix Sustained Release Dosage Forms, Pharm. Ind., 63:624-629 (2001). cited by applicant .
Duolite AP143/1093 Pharmaceutical Grade Anion Exchange Resin, Product Data Sheet, pp. 1-3 (Nov. 2004). cited by applicant .
Eliminating Polymorphism, Ion Exchange Resins-Healthcare, Rohm Haas, www.F:/Heathcare.sub.--Website/polymorph.htm (Feb. 9, 2006). cited by applicant .
El-Samaligy, Formulation and Evaluation of Sustained-Release Dextromethorphan Resinate Syrup, Egyptian Journal of Pharmaceutical Sciences, 37(1-6):509-519 (1996). cited by applicant .
Erdmann, Coating of Different Drugs with Optimized Kollicoat EMM 30 D Coatings, BASF Aktiengesellschaft, Proceedings of the 26.sup.th CRS symposium (Jun. 1999), 6313. cited by applicant .
Extended Release, RohmHaas Ion Exchange Resins-Healthcare, p. 1, Rohm and Haas website, www.rohmhaas.com (Feb. 9, 2005). cited by applicant .
Generic Drug Formulations with Kollicoat.RTM. SR 30 D and Kollidon.RTM. SR, pp. 1-51, BASF (1999). cited by applicant .
Generic Drug Formulations, MEF/EP076 (2007). cited by applicant .
Guide-Choosing the Right Functional Polymer, pp. 1, www.F:/HeathcareWebsite/guide.htm (Feb. 9, 2006). cited by applicant .
Haddish-Berhane, Modeling Film-Coat Non-Uniformity in Polymer Coated Pellets: A Stochastic Approach, International Journal of Pharmaceutics, 12; 323(1-2):64-71 (Oct. 2006; E-publication Jun. 6, 2006). cited by applicant .
Hossel, Cosmetics and Toiletries, 111(8):73 (1976). cited by applicant .
Hughes, New Uses of Ion Exchange Resins in Pharmaceutical Formulation, Rohm Haas (2004). cited by applicant .
Ichikawa, Use of Ion-Exchange Resins to Prepare 100 .mu.m-Sized Microcapsules with Prolonged Drug-Release by the Wurster Process, International Journal of Pharmaceutics 216:67-76 (Mar. 2001). cited by applicant .
Ion Exchange Resins, GB/US (Jan. 2004). cited by applicant .
Ion Exchange Resins-Healthcare, Rohm Haas, Frequently Asked Questions, pp. 1-3, www.F:/Heathcare.sub.--Website/gaq.sub.--print.htm (Feb. 9, 2006). cited by applicant .
Improved Dissolution of Poorly Soluble Drugs References, pp. 1, www.F:/Heathcare.sub.--Website/Poor.sub.--Solubility.sub.--refl.htm (Feb. 9, 2006). cited by applicant .
Kollicoat SR30D, Technical Information (Jan. 2004, Supercedes Jun. 1999) BASF, MEF/EP 073. cited by applicant .
Kollicoat SR30D, Technical Information, Bulletin, MEV96 (Jun. 1999). cited by applicant .
Kollicoat SR30D, Technical Information, ME36(e), pp. 1-14 (Jun. 1999). cited by applicant .
Kollicoat SR30D, Technical Information, MEMP30(e)-01, pp. 1-13 (Jan. 2004). cited by applicant .
Kollicoat.RTM.--Film-Coating Technology by BASF, www.pharma-solutions.basf.com, BASF-Expertise in Health and Nutrition, pp. 13 (Dec. 2, 2004). cited by applicant .
Kollicoat.RTM. SR 30 D, Polyvinyl Acetate Dispersion for Sustained-Release Pharmaceutical Formulations, Technical Information, BASF (Jun. 1999). cited by applicant .
Kollicoat.RTM. SR 30 D, Tackiness of Films as a Function of Type and concentration of Plasticizer, BASF-Expertise in Health and Nutrition (Dec. 2007). cited by applicant .
Kolter, BASF, ExAct, 5:1-5 (Oct. 2000). cited by applicant .
Kolter, Coated Drug Delivery Systems Based on Kollicoat.RTM. SR 30D, BASF, MEF/EP073 (Spring/Summer 2004). cited by applicant .
Kolter, Influence of Additives on the Properties of Films and coated Dosage Forms, BASF ExAct, 5:4 (Oct. 2000). cited by applicant .
Kolter, Influence of plasticizers on the Physico-Chemical Properties of Kollicoat.RTM. SR 30 D-Films, BASF Aktiengesellschaft (Spring/Summer 2004). cited by applicant .
Kolter, Kollicoat.RTM. SR 30 D A New Sustained Release Excipient, BASF AG, p. 1 (Nov. 1999). cited by applicant .
Kolter, Kollicoat.RTM. SR 30 D, Coated Drug Delivery Systems, ExAct, 11:3 (Oct. 2003). cited by applicant .
Markowitz, Advances in the Pharmacotherapy of Attention-Deficit-Hyperactivity Disorder: Focus on Methylphenidate Formulations, Pharmacotherapy, 23(10):1281-99 (posted Oct. 23, 2003). cited by applicant .
MIES, BASF, Pharmasolutions, MEMPD 130, Correlation of Drug Permeation Through Isolated Films and Coated Dosage Forms Based on Kollicoat 30SR D/IR, 2004 AAPS Annual Meeting and Exposition (Nov. 7-11, 2004). cited by applicant .
Nisar-UR-Rahman, Differential Scanning Calorimetry and Surface Morphology Studies on Coated Pellets using Aqueous Dispersions, Pakistan Journal of Pharmaceutical Sciences, 18(2):19-23 (Apr. 2005). cited by applicant .
Novartis Consumer Health in Canada, DELSYM, www.Novartisconsumerhealth.ca/en/products/delsym.shtml (2003). cited by applicant .
Nicotine, Ion Exchange Resins-Healthcare, Rohm Haas, www.F:/HeathcareWebsite/nicotin.htm (Feb. 9, 2006). cited by applicant .
Pearnchob, Coating with Extended Release, ExAct, 12:2-5 (Jun. 2004). cited by applicant .
Product Literature, Concerta.RTM., (methylphenidate HC1) Extended-release Tablets, (revised Nov. 2010). cited by applicant .
Product Literature, Daytrana.TM. (methylphenidate transdermal system) (revised Dec. 2009). cited by applicant .
Product Literature, Focalin.TM. XR (dexmethylphenidate hydrochloride) extended-release capsules, Novartis Consumer Health, 2004. cited by applicant .
Product Literature, Once Daily Metadate CD.TM.(methylphenidate HC1, USP) Extended-Release Capsules (Feb. 2007). cited by applicant .
Product Literature, Ritalin.RTM. hydrochloride methylphenidate hydrochloride tablets USP and Ritalin-SR.RTM. methylphenidate hydrochloride USP sustained-release tablets (revised Dec. 2010). cited by applicant .
Polymorphism References, pp. (Feb. 9, 2006) 1, www.F:/Heathcare.sub.--Website/polymorph references.htm, (Feb, 9, 2006). cited by applicant .
Publications-Ion Exchange Resins-Healthcare, Rohm Haas, www.F:/Heathcare.sub.--Website/publications.htm (Feb. 9, 2006). cited by applicant .
Quadir, FDA Excipient Workshop, Development of High Functionality Excipients for Immediate and Sustained Release Dosage Forms (Sep. 20, 2004). cited by applicant .
Raghunathan, Sustained-release Drug Delivery System 1: Coated ion-exchange Resin System for Phenylpropanolamine and Other Drugs, Journal of Pharmaceutical Science, 70:379-384 (Apr. 1981). cited by applicant .
Reduced Abuse Formulations, Ion Exchange Resins-Healthcare, Rohm Haas, www.F:/Heathcare.sub.--Website/reduced.sub.--Abuse.htm (Feb. 9, 2006). cited by applicant .
Robinson, Sustained and Controlled Release Drug Delivery Systems, Drugs and the Pharmaceutical Sciences, A Series of Textbooks and Monographs, vols. 1-6, pp. 130-210, by Marcel Dekker, Inc., New York and Basel (1978). cited by applicant .
Rowe, Materials Used in the Film Coating of Oral Dosage Forms, Critical Reports in Applied Chemistry, 6:1-16 (1984). cited by applicant .
Sawicki, Compressibility of Floating Pellets with Verapamil Hydrochloride Coated with Dispersion Kollicoat SR 30 D, European Journal of Pharmaceutics and Biopharmaceutics, 60(1):153-8 (May 2005; E-publication: Jan. 8, 2005). cited by applicant .
Jeong, Drug Release Properties of Polymer Coated Ion-Exchange Resin Complexes: Experimental and Theoretical Evaluation, Journal of Pharmaceutical Sciences, pp. 1-15 (Apr. 2006). cited by applicant .
Jeong, Development of Sustained Release Fast-melting Tablets Using Ion Exchange Resin Complexes (accepted Nov. 29, 2005), Dissertations Submitted to Purdue University, W. Lafayette, Indiana, UMI #3210729. cited by applicant .
Jeong, Evaluation of Drug Release Properties from Polymer Coated Drug/Ion-Exchange Resin Complexes Using Mathematical Simulation and Their Application into Sustained Oral Drug Delivery, Department of Pharmaceutical Chemistry, University of Kansas, Abstract (Jun. 16-18, 2005), pp. 92-105, 114, 141, 169 (Dec. 2005). cited by applicant .
Shao, Drug Release Form Kollicoat SR 30D-Coated Nonpareil Beads: Evaluation of Coating Level, Plasticizer Type, and Curing Condition, pp. 1-9, PharmSci Tech, 3(2):article 15 (Jun. 2002). cited by applicant .
Shao, Effects of Formulation Variables and Post-Compression Curing on Drug Release from a New Sustained-Release Matrix Material: Polyvinylacetate-Povidone, Pharmaceutical Development and Technology, 6(2):247-254 (2001). cited by applicant .
Strubing, Mechanistic Analysis of Drug Release From Tablets with Membrane Controlled Drug Delivery, European Journal of Pharmaceutics and Biopharmaceuticals, 66(1):113-9 (Apr. 2007; E-publication: Sep. 28, 2006). cited by applicant .
Swarbrick, Suspensions in Remington: The Science and Practice of Pharmacy, 20.sup.th Edition, ed. Gennaro, Lippincott, 2000, pp. 316-323. cited by applicant .
Tablet Disintegrate, Ion Exchange Resins-Healthcare, Rohm Haas, pp. 1, www.F:/Heathcare.sub.--Website/deliquescence.htm (Feb. 9, 2006). cited by applicant .
Taste Masking, Ion Exchange Resins-Healthcare, Rohm Haas, pp. 1, www.F:/Heathcare.sub.--Website/tastemasking.htm (Feb. 9, 2006). cited by applicant .
Taste Masking References, www.F:/Heathcare Website/taste.sub.--refl.htm (Feb. 9, 2006). cited by applicant .
Voskoboinikova, Drug Synthesis Methods and Manufacturing Technology, Modern Auxiliary Substances in Tablet Production: Use of High-Molecular-Weight Compounds for the Development of New Medicinal Forms and Optimization of Technological Processes, Pharmaceutical Chemistry Journal, 39(1):22-28 (Jan. 2005). cited by applicant .
Ahmann, Placebo-Controlled Evaluation of Amphetamine Mixture-Dextroamphetamine Salts and Amphetamine Salts (Adderall): Efficacy Rate and Side Effects, Pediatrics, 1:1-11 (Jan. 2001). cited by applicant .
Prabhu, Comparison of Dissolution Profiles for Sustained Release Resinates of BCS Class 1 Drugs Using USP Apparatus 2 and 4: A Technical Note, AAPS PhannSciTech, 9(3):769-773 (Sep. 2008). cited by applicant .
Adderall.RTM. Product Insert, revised Mar. 2007 and Adderall XR.RTM. Product Insert (revised Dec. 2013). cited by applicant .
Hinsvark, The oral bioavailability and pharmacokinetics of soluble and resin-bound forms of amphetamine and phentermine in man, Journal of Pharma and BioPharma, 1(4):319-328 (Aug. 1973). cited by applicant .
Hadzija, Determination of Hydrocodone in Tussion.RTM. Extended-Release Suspension by High-Performance Liquid Chromatography (HPLC), Journal of Forensic Science, 41(5):878-880 (Sep. 1996). cited by applicant .
Physician's Desk Reference: Adderall, 51st Ed. (1997). cited by applicant .
Lehmann, Coating of Multiparticulates Using Polymeric Solutions, Formulations and Process Considerations, Multiparticulate Oral Drug Delivery, Ghebre-Sellassie, Ed., Marcel Dekker, Inc., NY, 1994. cited by applicant .
Remington: The Science and Practice of Pharmacy, 19th Ed., vol. II, pp. 1653-1658 (1995). cited by applicant .
Lin, Bioavailability of d-pseudoephedrine and azatadine from a repeat action tablet formulation, Journal of International Medical Research, 10(2):122-125 (1982). cited by applicant .
Lin, Comparative bioavailability of d-pseudoephedrine from a conventional d-pseudoephedrine sulfate tablet and from a repeat action tablet, Journal of International Medical Research 10(2):126-128 (1982). cited by applicant .
Lasser, Comparative Efficacy and Safety of Lisdexamfetamine Dimesylate and Mixed Amphetamine Salts Extended Release in Adults with Attention Deficit/Hyperactivity Disorder, Primary Psychiatry, 17(9):44-54 (2010). cited by applicant .
FDA Guidance for Industry, SUPAC-MR: Modified Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vitro Bioequivalence Documentation, pp. 1-36 (Sep. 1997). cited by applicant .
The United States Pharmacopeia 23, National Formulary 18, pp. 1791-1799 (1995). cited by applicant .
Center of Drug Evaluation and Research, Guidance for Industry: Statistical Approaches to Establishing Bioequivalence, pp. 1-45 (Jan. 2001). cited by applicant .
Remington: Pharmaceutical Science, 15th Ed., pp. 1618, 1625-1626 (1975). cited by applicant .
FDA Guidance for Industry: Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances, pp. 1-35 (Jun. 14, 2006). cited by applicant .
International Search Report dated Oct. 1, 2007 issued in International Patent Application No. PCT/US2007/006572. cited by applicant .
International Search Report and the Written Opinion of the International Search Report of International Patent Application No. PCT/US2011/024873 dated Feb. 22, 2012. cited by applicant .
Communication dated Jul. 1, 2011 issued in European Patent Application No. 07753217.4. cited by applicant .
Communication dated Nov. 22, 2010 and Response dated Mar. 25, 2011 issued in European Patent Application No. 07753217.4. cited by applicant .
Communication dated Jan. 5, 2009 issued in European Patent Application No. 07753217.4. cited by applicant .
Communication dated Nov. 26, 2008 and Response dated Dec. 17, 2008 issued in European Patent Application No. 07753217.4. cited by applicant .
Extended European Search Report dated Feb. 1, 2012 issued in European Patent Application No. 11192711.7. cited by applicant .
Office Action with translation dated Jan. 28, 2011 issued in Russian Patent Application No. 2008140944. cited by applicant .
Response to Office Action with translation dated Apr. 5, 2011 issued in Israeli Patent Application No. 194042. cited by applicant .
First Examiners Report dated Nov. 28, 2011 issued in Australian Patent Application No. 2007227569. cited by applicant .
Response to the First Examiners Report dated Nov. 28, 2011 issued in Australian Patent Application No. 2007227569. cited by applicant .
Notification of Grounds of Refusal dated Aug. 25, 2013 issued in Korean Patent Application No. 10-2008-7024357. cited by applicant .
Notice of Grounds for Preliminary Rejection dated Apr. 4, 2014 issued in Korean Patent Application No. 10-2008-7024357. cited by applicant .
Office Action issued in Japanese Patent Application No. 2009-500494, English translation of Notice of Reasons for Rejection, bibliography from official gazettes, and excerpts of four "references" dated Aug. 21, 2012. cited by applicant .
Response filed Sep. 11, 2013 to the Office Action issued in Japanese Patent Application No. 2009-500494 dated Aug. 21, 2012. cited by applicant .
Office Action dated Mar. 19, 2013 issued in Japanese Patent Application No. 2009-500494. cited by applicant .
English translation of the amended claims filed in response to the Office Action dated Mar. 19, 2013 issued in Japanese Patent Application No. 2009-500494. cited by applicant .
First Office Action issued in Canadian Patent Application No. 2645855 on Mar. 18, 2013. cited by applicant .
Response filed Sep. 18, 2013 to the First Office Action issued in Canadian Patent Application No. 2645855. cited by applicant .
Office Action issued in Canadian Patent Application No. 2645855 on Dec. 9, 2013. cited by applicant .
Response filed Jun. 9, 2014 to the Office Action issued in Canadian Patent Application No. 2645855 on Dec. 9, 2013. cited by applicant .
Supplemental Response filed Jun. 23, 2014 to the Office Action issued in Canadian Patent Application No. 2645855 on Dec. 9, 2013. cited by applicant .
Translation of the First Office Action issued in Chinese Patent Application No. 201110371263.X on Feb. 6, 2013. cited by applicant .
Translation of the Second Office Action issued in Chinese Patent Application No. 201110371263.X on Oct. 24, 2013. cited by applicant .
Non-Final Office Action dated Nov. 12, 2009 with Response dated Mar. 12, 2010 in U.S. Appl. No. 11/724,966. cited by applicant .
Final Office Action dated Jun. 23, 2010 with Response dated Sep. 23, 2010 in U.S. Appl. No. 11/724,966. cited by applicant .
Non-Final Office Action dated Nov. 26, 2010 with Response dated May 25, 2011 in U.S. Appl. No. 11/724,966. cited by applicant .
Declaration Pursuant to 37 CFR 1.132 by Dr. Kibbe and Declaration Pursuant to 37 CFR 1.132 by Dr. Tu filed in U.S. Appl. No. 11/724,966. cited by applicant .
Rule 131 Declaration filed Sep. 23, 2010 in U.S. Appl. No. 11/724,966. cited by applicant .
Notice of Allowance dated Aug. 19, 2011 issued in U.S. Appl. No. 11/724,966. cited by applicant .
Office Action dated Dec. 23, 2011 issued in U.S. Appl. No. 13/244,706. cited by applicant .
Amendment, Response and Declaration filed Mar. 7, 2012 in response to the Office Action on Dec. 23, 2011 in U.S. Appl. No. 13/244,706. cited by applicant .
Final Office Action dated Jun. 15, 2013 issued in U.S. Appl. No. 13/244,706. cited by applicant .
Response dated Jul. 23, 2012 to the Final Office Action dated Jun. 15, 2013 issued in U.S. Appl. No. 13/244,706. cited by applicant .
Notice of Allowance dated Aug. 13, 2012 issued in U.S. Appl. No. 13/244,706. cited by applicant .
Office Action dated Dec. 9, 2011 issued in U.S. Appl. No. 13/244,748. cited by applicant .
Amendment, Response and Declaration, filed Mar. 9, 2012 in Response to the Office Action dated Dec. 9, 2011 in U.S. Appl. No. 13/244,748. cited by applicant .
Notice of Allowance dated Apr. 27, 2012 issued in U.S. Appl. No. 13/244,748. cited by applicant .
Office Action dated Dec. 9, 2011 issued in U.S. Appl. No. 12/722,857. cited by applicant .
Notice of Allowance dated Aug. 30, 2012 issued in U.S. Appl. No. 12/722,857. cited by applicant .
Office Action dated Jan. 18, 2013 in U.S. Appl. No. 13/666,424 and Response dated Apr. 17, 2013 to the Office Action. cited by applicant .
Notice of Allowance dated May 17, 2013 issued in U.S. Appl. No. 13/666,424. cited by applicant .
Office Action dated Dec. 5, 2013 issued in U.S. Appl. No. 14/065,842. cited by applicant .
Office Action dated Dec. 5, 2013 and Response dated Feb. 10, 2014 in U.S. Appl. No. 14/065,842. cited by applicant .
Notice of Allowance dated Apr. 9, 2014 issued in U.S. Appl. No. 14/065,842. cited by applicant .
Office Action dated Nov. 21, 2013 issued in U.S. Appl. No. 14/044,105. cited by applicant .
Applicant Initiated Interview Summary dated May 13, 2014 in U.S. Appl. No. 14/044,105. cited by applicant .
Office Action dated Nov. 21, 2013 and Response dated Jan. 24, 2014 in U.S. Appl. No. 14/044,105. cited by applicant .
Notice of Allowance dated May 13, 2014 issued in U.S. Appl. No. 14/044,105. cited by applicant .
Non-Final Office Action dated Mar. 21, 2013 and issued in U.S. Appl. No. 13/746,654 and Response. cited by applicant .
Notice of Allowance dated Jul. 31, 2013 issued in U.S. Appl. No. 13/746,654. cited by applicant .
Non-Final Office Action dated Feb. 26, 2014 issued in U.S. Appl. No. 14/155,410 and Response. cited by applicant .
Notice of Allowance dated Jul. 21, 2014 and issued in U.S. Appl. No. 14/155,410. cited by applicant .
Non-Final Office Action dated Nov. 9, 2012 and Response in U.S. Appl. No. 13/611,183. cited by applicant .
Notice of Allowance dated May 10, 2013 issued in U.S. Appl. No. 13/611,183. cited by applicant .
Interview Summary dated May 10, 2013 issued in U.S. Appl. No. 13/611,183. cited by applicant .
Notice of Allowance dated Aug. 2, 2013 issued in U.S. Appl. No. 13/905,808. cited by applicant .
Office Action dated Nov. 21, 2013 and Response in U.S. Appl. No. 14/016,384. cited by applicant .
Notice of Allowance dated Apr. 9, 2014 issued in U.S. Appl. No. 14/016,384. cited by applicant .
Office Action dated Aug. 1, 2014 issued in U.S. Appl. No. 14/300,580. cited by applicant .
Claims filed on Mar. 18, 2014 in U.S. Appl. No. 13/844,555. cited by applicant .
Claims filed on May 2, 2014 in U.S. Appl. No. 13/844,537. cited by applicant .
Claims filed on Mar. 18, 2014 in U.S. Appl. No. 13/844,510. cited by applicant .
Notice of Paragraph IV Certification from Par Pharmaceuticals, dated Dec. 11, 2014 and "Detailed Statement of the Factual and Legal Bases for Par's Opinion that U.S. Pat. No. 8,062,667; 8,287,903; 8,465,765; 8,563,033; and 8,778,390 are Invalid, Unenforceable, and/or Will Not Be Infringed." cited by applicant .
Notice of Paragraph IV Certification from Actavis, dated Sep. 3, 2014 and "Detailed Factual and Legal Bases for Actavis's Paragraph IV Certification that U.S. Pat. No. 8,062,667; 8,287,903; 8,465,765; 8,563,033; and 8,778,390 are Invalid, Unenforceable, and/or Not Infringed." cited by applicant .
Ansel et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, 6.sup.th Ed. pp. 213-221. Williams & Watkins. 1995. cited by applicant .
Pelham et al. Once-a-Day Concerta Methylphenidate Verses Three-Times-Daily Methylphenidate in Laboratory and Natural Settings. Pediatrics. vol. 107(6):1-15. Jun. 1, 2001. cited by applicant .
Greenhill et al. Double-Blind, Placebo-Controlled Study of Modified-Release Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder. Pediatrics. vol. 109(3):1-7. Mar. 1, 2002. cited by applicant .
Swanson et al. Comparison of Once-Daily Extended-Release Methylphenidate Formulations in Children With Attention-Deficit/Hyperactivity Disorder in the Laboratory School (The Comacs Study). Pediatrics. vol. 113(3):206-216. Mar. 3, 2004. cited by applicant .
Product Literature, Concerta.RTM., (methylphenidate HCI) Extended-release Tablets, rev Nov. 2010. cited by applicant .
Product Literature, Daytrana.RTM. (methylphenidate transdermal system), revised Dec. 2009. cited by applicant .
Metadate CD.RTM., Product Label, 2013. cited by applicant .
Metadate CD.RTM. NDA Approval Letter from the Department of Health and Human Services, dated Feb. 2, 2001. cited by applicant .
Quillivant.RTM. XR, Highlights of Prescribing Information, Label Revised Dec. 2013. cited by applicant .
Quillivant.RTM. XR NDA Approval Letter from the Department of Health and Human Services, dated Sep. 27, 2012. cited by applicant .
Focalin.RTM. XR, Highlights of Prescribing Information, Label Revised Jan. 2012. cited by applicant .
Focalin.RTM. XR NDA Approval Letter from the Department of Health and Human Services, dated May 26, 2005. cited by applicant .
Methylin.RTM. ER NDA Approval Letter from the Department of Health and Human Services, dated May 9, 2000. cited by applicant .
Ritalin-SR.RTM., Product Label, Dec. 13, 2013. cited by applicant .
Ritalin-SR.RTM. NDA Approval Letter from the Department of Health and Human Services, dated May 21, 2004. cited by applicant .
Ritalin-LA.RTM., Product Label, Dec. 13, 2013. cited by applicant .
Ritalin-LA.RTM. NDA Approval Letter from the Department of Health and Human Services, dated Jun. 5, 2002. cited by applicant .
Kathala, U.S. Appl. No. 15/200,625, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 15/200,617, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 15/200,748, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 15/200,786, filed Jul. 1, 2016. cited by applicant .
Mehta, U.S. Appl. No. 14/679,427, filed Apr. 6, 2015. cited by applicant .
Mehta, U.S. Appl. No. 14/679,438, filed Apr. 6, 2015. cited by applicant.
1. An aqueous pharmaceutical liquid suspension suitable for oral ingestion comprising: (i) a particulate drug-ion exchange resin complex-matrix comprising a pharmaceutically acceptable drug which is carbinoxamine bound to a pharmaceutically acceptable water insoluble ion exchange resin to form said particulate drug-ion exchange resin complex, said particulate drug-ion exchange resin complex being in a matrix with a water insoluble polymer or copolymer or a hydrophilic polymer, which polymer or copolymer is present in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex-matrix, said ion exchange resin being a cation exchange resin, and (ii) a cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric diffusion modified release barrier coating over said particulate drug-ion exchange resin complex defined in (i), said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release, diffusion barrier coating applied as an aqueous dispersion, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating comprises: (a) about 75% w/w to about 90% w/w polyvinylacetate polymer; (b) a stabilizer comprising polyvinylpyrrolidone, and (c) about 2.5% w/w to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured, high tensile strength, water permeable, water insoluble, non- ionic polymeric, modified release diffusion barrier coating, whereby said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release, diffusion barrier coating is over the particulate drug-ion exchange resin complex-matrix and provides a modified release profile to said pharmaceutically acceptable drug in said particulate drug- ion exchange resin complex-matrix.
2. The suspension according to claim 1, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release, diffusion barrier coating has an elongation factor of between about 125% and about 400%.
3. The suspension according to claim 1, wherein said particulate drug-ion exchange resin complex-matrix of (i) is capable of passing through a number 40 mesh screen.
4. The suspension according to claim 1, wherein said particulate drug-ion exchange resin complex-matrix of (i) comprises about 5% to about 20% by weight of said water insoluble polymer or copolymer or a hydrophilic polymer.
5. The suspension according to claim 1, wherein said particulate drug-ion exchange resin complex-matrix comprises said particulate drug-ion exchange resin complex and said hydrophilic polymer.
6. The suspension according to claim 5, wherein said hydrophilic polymer in said particulate drug-ion exchange resin complex-matrix comprises polyvinylpyrrolidone.
7. The suspension according to claim 1, wherein said particulate drug-ion exchange resin complex-matrix comprises said particulate drug-ion exchange resin complex and said water insoluble polymer or copolymer.
8. The suspension according to claim 7, wherein said water insoluble polymer in said particulate drug-ion exchange resin complex-matrix comprises polyvinylacetate, wherein said particulate matrix comprises said particulate drug-ion exchange resin complex, a stabilizer comprising polyvinylpyrrolidone and an effective amount of a surfactant.
9. The suspension according to claim 1, further comprising an orally ingestible drug bound to a pharmaceutically acceptable, water insoluble ion exchange resin to form an uncoated particulate drug-ion exchange resin complex, wherein said drug in said uncoated complex is either the same as or different from the pharmaceutically acceptable drug in (i).
10. The suspension according to claim 1, wherein said plasticizer comprises about 5% to about 10% w/w of said cured modified release barrier coating.
11. The suspension according to claim 10, wherein said plasticizer comprises triacetin.
12. The suspension according to claim 1, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating further comprises a surfactant.
13. The suspension according to claim 1, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating comprises about 25% to about 50% by weight of the particulate drug-ion exchange resin complex-matrix defined in (i).
14. The suspension according to claim 13, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating comprises about 30% to about 45% by weight of the particulate barrier coated drug-ion exchange resin complex-matrix defined in (i).
15. An aqueous pharmaceutical liquid suspension suitable for oral ingestion comprising: (i) a particulate carbinoxamine-cation exchange resin complex comprising carbinoxamine bound to a pharmaceutically acceptable water insoluble cation exchange resin to form said particulate carbinoxamine-cation exchange resin complex, said particulate carbinoxamine-cation exchange resin complex optionally being in a matrix with a water insoluble polymer or copolymer or a hydrophilic polymer, and (ii) a cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating over said particulate carbinoxamine-cation exchange resin complex-optional matrix defined in (i), said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating applied as an aqueous dispersion, wherein said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating comprises: (a) about 75% w/w to about 90% w/w polyvinylacetate polymer; and (b) a stabilizer comprising polyvinylpyrrolidone, and (c) about 2.5% w/w to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating, whereby said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating is over the particulate carbinoxamine-cation exchange resin complex-optional matrix and provides a modified release profile to said pharmaceutically acceptable drug in said particulate carbinoxamine-cation exchange resin complex-optional matrix.
16. The suspension according to claim 15, wherein the matrix is present and comprises the particulate carbinoxamine-cation exchange resin complex and about 3% to about 30% by weight of the hydrophilic polymer, based on the weight of the particulate carbinoxamine-cation exchange resin complex-matrix.
17. The suspension according to claim 15, wherein the matrix is present and comprises the particulate carbinoxamine-cation exchange resin complex and about 5% to about 20% by weight of the hydrophilic polymer, based on the weight of the particulate carbinoxamine-cation exchange resin complex-matrix.
18. An aqueous pharmaceutical liquid suspension suitable for oral ingestion comprising: (i) a particulate carbinoxamine-cation exchange resin complex-matrix comprising carbinoxamine bound to a pharmaceutically acceptable water insoluble cation exchange resin to form said particulate carbinoxamine-cation exchange resin complex-matrix, wherein the matrix comprises the particulate carbinoxamine-cation exchange resin complex and a polymer or copolymer in an amount of about 3% to about 30% of the particulate carbinoxamine-cation exchange resin complex-matrix; and (ii) about 25% w/w to about 50% w/w cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating over said particulate carbinoxamine-cation exchange resin complex defined in (i), said cured, high tensile strength, water permeable, water insoluble, non-ionic polymeric, modified release diffusion barrier coating over the particulate carbinoxamine-cation exchange resin complex-matrix and provides a modified release profile to said pharmaceutically acceptable drug in said particulate carbinoxamine-cation exchange resin complex-matrix.
19. The suspension according to claim 18, wherein the modified release barrier coating is present in an amount of about 30% w/w to about 45% w/w of the barrier coated particulate carbinoxamine-cation exchange resin complex.
An example of an anion exchange resin is a cholestyramine resin, a strong base type 1 anion exchange resin powder with a polystyrene matrix and quarternary ammonium functional groups. The exchangeable anion is generally chloride which can be exchanged for, or replaced by, virtually any anionic species. A commercially available Cholestyramine resins is PUROLITE.TM. A430MR resin. As described by its manufacturer, this resin has an average particle size range of less than 150 microns, a pH in the range of 4-6, and an exchange capacity of 1.8-2.2 eq/dry gm. Another pharmaceutical grade cholestyramine resin is available as DUOLITE.TM. AP143/1094 [Rohm and Haas], described by the manufacturer as having a particle size in the range of 95%, less than 100 microns and 40%, less than 50 microns. The commercial literature from the suppliers of these and other resin is incorporated herein by reference (PUROLITE A-430 MR; DOW Cholestryramine USP, Form No. 177-01877-204, Dow Chemical Company; DUOLITE AP143/1083, Rohm and Haas Company, IE-566EDS--February 2006).
Cation exchange resins, e.g., AMBERLITE IRP-69, are particularly well suited for use with drugs and other molecules having a cationic functionality, including, e.g., acycloguanosine, timidazole, deferiprone, cimetidine, oxycodone, remacemide, nicotine, morphine, hydrocodone, rivastigmine, dextromethorphan, propanolol, betaxolol, 4-aminopyridine, chlorpheniramine, paroxetine, duloxetine HCl, atomoxetine HCl, risperidone, atovaquone, esmolol, naloxone, phenylpropranolamine, gemifloxacin, oxymorphone, hydromorphone, nalbupherin, and O-desmethylvenlafaxine, as well as prodrugs, salts, isomers, polymorphs, and solvates thereof, as well as other drugs identified herein and/or known in the art. Cationic exchange resins are readily selected for use of these basic drugs or other drugs identified herein and/or are those which are known to those of skill in the art.
The drugs that are suitable for use in these preparations include drugs for the treatment of respiratory tract disorders such as, for example, antitussive expectorants such as dihydrocodeine phosphate, codeine phosphate, noscapine hydrochloride, phenylpropanolamine hydrochloride, potassium guaiacolsulfonate, cloperastine fendizoate, dextromethorphan hydrobromide and cloperastine hydrochloride; bronchodilators such as dl-methylephedrine hydrochloride and dl-methylephedrine saccharinate; and antihistamines such as fexofenadine HCl- or dl-chlorpheniramine maleate. Other drugs useful for the invention include drugs for the treatment of digestive tract disorders such as, for example, digestive tract antispasmodics, including scopolamine hydrobromide, metixene hydrochloride and dicyclomine hydrochloride, drugs for the treatment of central nervous system disorders such as, for example, antipsychotic drugs including phenothiazine derivatives (chlorpromazine hydrochloride, etc.) and phenothiazine-like compounds (chlorprothexene hydrochloride, etc.) antianxiety drugs such as benzodiazepine derivatives (chlordiazepoxide hydrochloride, diazepam, etc.), alprazolam, etc., antidepressants such as imipramine compounds (imipramine hydrochloride, etc.), respiradone, SSRIs like sertraline HCl, paroxitene HCl, venlafaxine HCl, etc., antipyretic analgesics such as sodium salicylate, and hypnotics such as phenobarbital sodium; opioid analgesics drugs such as alfentanil, allyprodine, alphaprodine, anileridne, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, cyclazocine, desmorphine, dextromoramide, dexocine, diampromide, dihydrocodeine, dihydromorphine, dimexoxadol, dimepheptanol, dimethylthiambutene, dioxaphetly butyrate, dipipanone, eptazocine, ethotheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene fentanyl, heroin, hydrocodone, hydromorphone, hydroxpethidine, isomethadone, ketobermidone, levallorphan, levorphanol, levophenacylmorphan, lofentanil, meperidine, meptazinol metazocine, methadone, metopon, morphine, morphine sulfate, myrophine, nalbuphine, narceine, cicomorphine, norlevorphanol, nomethadonel nalorphine, normophine, norpipanone, opium, oxycodone, ixmymorphone, papavreturn, pentazocine, phenadoxone, phenmorphan, phenazocine, phenoperidine, iminodine, piritamide, propheptazine, promedol, properidine, propiram, proposyphene, sufenanil, tramadol, tiline, salts thereof, mixtures of any of the foregoing, mixed mu-agonists/antagonists, mu-antagonist combinations, and the like; and drugs for the treatment of respiratory system disorders such as, for example, coronary dilators including etafenone hydrochloride, calcium antagonists such as verapamil hydrochloride, hypotensive drugs such as hydrazine hydrochloride, propranolol hydrochloride and clonidine hydrochloride, a peripheral vasodilators/vasoconstrictors such as tolazoline hydrochloride, respiradone, other respiratory agents such as predinisolone, prednisolone sodium phosphate, albuterol, albuterol sulfate, terbutaline, etc. Antibiotics may also be useful including macrolides such as, oleandomycin phosphate, tetracyclines such as tetracycline hydrochloride, streptomycins such as fradiomycin, sulfate, and penicillin drugs such as amoxicillin, dicloxacillin sodium, pivmecillinam hydrochloride and carbenicillinindanly sodium. Chemotherapeutic drugs may also be used including sulfa drugs such as sulfisomidine sodium, antituberculosis drugs such as kanamycin sulfate, and antiprotozoan drugs such as amodiaquine hydrochloride. An excellent sustained releasing effect is obtained in basic drugs for the respiratory tract such as dihydrocodeine phosphate, dl-methyl-ephedrine hydrochloride and phenylpropanolamine hydrochloride. Acidic drugs that can be used in the present invention include, for example, dehydrocholic acid, diflunisal, ethacrynic acid, fenoprofen, furosemide, gemfibrozil, ibuprofen, naproxen, phenyloin, progencid, sulindac, theophylline, salicylic acid and acetylsalicylic acid. Basic drugs that can be used in the present invention include, for example, acetophenazine, amitriptyline, amphetamine, benztropine, biperiden, bromodiphenhydramine, brompheniramine, carbinoxamine, chloperastine, chlorcyclizine, chorpheniramine, chlorphenoxamine, chlorpromazine, clemastine, clomiphene, clonidine, codeine, cyclizine, cyclobenzaprine, cyproheptadine, desipramine, dexbrompheniramine, dexchlorpheniramine, dextroamphetamine, dextromethorphan, dicyclomine, diphemanil, diphenhydramine, doxepin, doxylamine, ergotamine, fluphenazine, haloperidol, hydrocodone, hydroxychloroquine, hydroxyzine, hyoscyamine, imipramine, levopropoxyphene, maprotiline, meclizine, mepenzolate, meperidine, mephentermine, mesoridazine, metformin, methadone, methylepherdine, methdilazine, methscopolamine, methysergide, metoprolol, nortriptylene, noscapine, nylindrin, oxybutynin, oxycodone, oxymorphone, orphenadrine, papaverine, pentazocine, phendimetrazine, phentermine, phenylephrine, phenylpropanolamine, pyrilamine, tripelennamine, triprolidine, promazine, propoxyphene, propanolol, pseudoephedrine, pyrilamine, quinidine, scopolamine, dextromethorphan, chlorpheniramine and codeine. Amphoteric drugs that can be used in the present invention include for example, aminocaproic acid, aminosalicylic acid, hydromorphone, isoxurprine, levorphanol, melphalan, morphine, nalidixic acid, and paraminosaliclic acid.
Useful preservatives include, but are not limited to, sodium benzoate, benzoic acid, potassium sorbate, salts of edetate (also known as salts of ethylenediaminetetraacetic acid, or EDTA, such as disodium EDTA), parabens (e.g., methyl, ethyl, propyl or butyl-hydroxybenzoates, etc.), and sorbic acid. Amongst useful preservatives include chelating agents some of which are listed above and other chelating agents, e.g., nitrilotriacetic acid (NTA); ethylenediaminetetracetic acid (EDTA), hydroxyethylethylenediaminetriacetic acid (HEDTA), diethylenetriaminepentaacetic acid (DPTA), 1,2-Diaminopropanetetraacetic acid (1,2-PDTA); 1,3-Diaminopropanetetraacetic acid (1,3-PDTA); 2,2-ethylenedioxybis[ethyliminodi(acetic acid)] (EGTA); 1,10-bis(2-pyridylmethyl)-1,4,7,10-tetraazadecane (BPTETA); ethylenediamine (EDAMINE); Trans-1,2-diaminocyclohexane-N,N,N',N'-tetraacetic acid (CDTA); ethylenediamine-N,N'-diacetate (EDDA); phenazine methosulphate (PMS); 2,6-Dichloro-indophenol (DCPIP); Bis(carboxymethyl)diaza-18-crown-6 (CROWN); porphine; chlorophyll; dimercaprol (2,3-Dimercapto-1-propanol); citric acid; tartaric acid; fumaric acid; malic acid; and salts thereof. The preservatives listed above are exemplary, but each preservative must be evaluated in each formulation, to assure the compatibility and efficacy of the preservative. Methods for evaluating the efficacy of preservatives in pharmaceutical formulations are known to those skilled in the art. Preferred preservatives are the paraben preservatives include methyl, ethyl, propyl, and butyl paraben. Methyl and propyl paraben are most preferable. Preferably, both methyl and propyl paraben are present in the formulation in a ratio of methyl paraben to propyl paraben of from about 2.5:1 to about 16:1, preferably 9:1.
Devices have been described, and many are commercially available, which provide for metered drug administration, including controlled infusion devices (e.g., for patient-controlled analgesia), metered-dose inhalers and implantable pumps. For example, various liquid metering devices for squeezable bottles have been described [U.S. Pat. Nos. 6,997,358, 3,146,919, filed in 1960, U.S. Pat. No. 3,567,079, filed in 1968, and in GB 2201395, filed in 1986.] A device for dispensing multiple compositions is provided in U.S. Pat. No. 6,997,219.
Methods and apparatus for delivery of drugs through nasogastric tubes are well known to those of ordinary skill in the art. See, e.g., E. Bryson, "Drug Administration via Nasogastric Tube", Nurs Times, 2001, Apr. 19-25 97(16):51. The present invention can be readily delivered using such devices. Suitable nasogastric tubes are available commercially and/or have been described. See, e.g., U.S. Pat. Nos. 5,334,166; 5,322,073; 4,619,673; 4,363,323.
The coating solution was prepared by dispersing 825 g of KOLLICOAT.TM. SR-30D polymer, 12 g of triacetin in 462 g of purified water and mixing for 1 hour. The coating process was performed in a VECTOR.TM. FLM-1 fluid bed processor by applying 1,200 g of the coating solution to 600 g of Pseudoephedrine Resin Complex using Wuster process that resulted in 40% weight gain. The coating conditions were controlled at an inlet temperature of about 68-72.degree. C., product temperature of 26-32.degree. C., air flow of 16-19 cfm, nozzle pressure of 2.5 kg/cm.sup.2, accelerator air pressure of 1.0 kg/cm.sup.2 and spray rate of 4-6 g/min so that uniform coating was achieved. The Coated Pseudoephedrine Resin Complex was then placed at 60.degree. C. for 5 hours for curing.
All patents, patent publications, and other publications listed in this specification, as well as priority documents U.S. patent application Ser. No. 14/155,410, filed Jan. 15, 2014; U.S. patent application Ser. No. 14/065,842, filed Oct. 29, 2013, now U.S. Pat. No. 8,747,902, issued Jun. 10, 2014; U.S. patent application Ser. No. 14/044,105, filed Oct. 2, 2013, now U.S. Pat. No. 8,790,700, issued Jul. 29, 2014; U.S. patent application Ser. No. 13/746,654, filed Jan. 22, 2013, now U.S. Pat. No. 8,597,684, issued Dec. 3, 2013; U.S. patent application Ser. No. 13/666,424, filed Nov. 1, 2012, now U.S. Pat. No. 8,491,935, issued Jul. 23, 2013; U.S. patent application Ser. No. 12/722,857, filed Mar. 12, 2010, now U.S. Pat. No. 8,337,890, issued Dec. 25, 2012; U.S. patent application Ser. No. 11/724,966, filed Mar. 15, 2007, now U.S. Pat. No. 8,062,667, issued Nov. 22, 2011; and U.S. Provisional Patent Application No. 60/783,181, filed Mar. 16, 2006, now expired, are incorporated herein by reference. While the invention has been described with reference to a particularly preferred embodiment, it will be appreciated that modifications can be made without departing from the spirit of the invention. Such modifications are intended to fall within the scope of the appended claims.

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 Application No. 07753217
 Application No. 07753217
 Application No. 07753217
 Application No. 07753217
 Application No. 11192711
 Application No. 2008140944
 Application No. 194042
 Application No. 2007227569
 Application No. 2007227569
 Application No. 10
 Application No. 10
 Application No. 2009
 Application No. 2009
 Application No. 2009
 Application No. 2009
 Application No. 2645855
 Application No. 2645855
 Application No. 2645855
 Application No. 2645855
 Application No. 2645855
 Application No. 201110371263
 Application No. 201110371263
 Application No. 60