Patent application EP16171320A (EP), filed 2016-05-25
Publication number: EP3248592A1
Title: PROCESS FOR THE PREPARATION OF DRUG DELIVERY SYSTEMS HAVING A TESTOSTERONE COMPOUND PRESENT IN AN OUTER LAYER OR PART, AS WELL AS SUCH DRUG DELIVERY SYSTEMS
Abstract: The invention relates to a process for preparing a time controlled, immediate release drug delivery system for oral administration of a first active ingredient to a subject in need thereof. The invention additionally relates to a dual drug delivery device, comprising the time controlled, immediate release drug delivery system according to the invention, further comprising a spray coating comprising a testosterone.
IPC codes: A61K  31/   506            A I
A61K  31/   519            A I
A61K  31/   568            A I
A61K   9/    00            A I
A61K   9/    24            A I
A61K   9/    28            A I
Claims: number: 1
text: A process for preparing dual drug delivery devices for oral administration of a second and first active ingredient to a subject in need thereof, said process comprising the steps of
number: 2
text: The process according to claim 1, wherein testosterone or the functional analogue thereof is spray coated using a solution comprising a film forming polymer and a solvent system based on ethanol and water.
number: 3
text: The process according to claim 2, wherein the film forming polymer is hydroxypropylmethylcellulose.
number: 4
text: The process according to claim 2 or 3, wherein the weight ratio ethanol/water is 6/4 - 8/2.
number: 5
text: The process according to any one of the preceding claims, wherein testosterone or the functional analogue thereof is spray coated using a solution further comprising a cyclodextrin, or a derivative or polymer thereof.
number: 6
text: The process according to any one of the preceding claims, wherein testosterone or the functional analogue thereof is spray coated using a solution further comprises a flavouring compound and/or a sweetener.
number: 7
text: The process according to any one of the preceding claims, wherein the first coating of step (i) is also applied using spray coating step.
number: 8
text: The process according to any one of the preceding claims, wherein the spray coating step ii) and/or in the embodiment of claim 7, the spray coating step in step (i) inclusive of its inherent drying step is carried out at temperatures up to maximally 55°C, preferably up to maximally 50°C, and more preferably at temperatures in the range of 35°C to 45°C.
number: 9
text: The process according to any one of the preceding claims, wherein the first coating around the core in step i) comprises ethylcellulose.
number: 10
text: The process according to claim 9, wherein the first coating is applied at a temperature of 60°C or higher; or wherein the provided time controlled, immediate release drug delivery system of step i) is subjected to a curing step.
number: 11
text: The process according to any one of the preceding claims, wherein the first active ingredient is Sildenafil or Buspirone.
number: 12
text: The process according to any one of the preceding claims wherein the spray coating step or step is/are carried out in a perforated pan coater or fluid bed coater.
number: 13
text: The dual drug delivery device obtainable by the process of any one of claims 1-12.
Office action: search_report, dated 2017-11-29
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: WO2012158030A2
ref_type: patent
severity: background
ref_id: WO9626940A1
ref_type: patent
severity: background
ref_id: WO2006027680A1
ref_type: patent
severity: background
ref_id: WO2007056546A1
ref_type: patent
severity: background
ref_id: WO2007106708A2
ref_type: patent
severity: background
ref_id: - VAN DER VOORT MAARSCHALK ET AL., INT J PHARMACEUTICS, vol. 151, 1997, pages 27 - 34
ref_type: npl
severity: background
ref_id: - VAN DER VOORT MAARSCHALK ET AL., PHARM RES, vol. 14, 1997, pages 415 - 419
ref_type: npl
severity: background
ref_id: - STEENDAM ET AL., J CONTROL REL, vol. 70, 2001, pages 71 - 82
ref_type: npl
severity: background
ref_id: - LAITY; CAMERON, EUR J PHARM BIOPHARM, vol. 75, 2010, pages 263 - 276
ref_type: npl
severity: background
ref_id: WO2012158030A2
ref_type: patent
severity: background
ref_id: WO2005107810A2
ref_type: patent
severity: background
ref_id: - KIM VAN ROOIJ ET AL: "Pharmacokinetics of a Prototype Formulation of Sublingual Testosterone and a Buspirone Tablet, Versus an Advanced Combination Tablet of Testosterone and Buspirone in Healthy Premenopausal Women", DRUGS IN R & D, vol. 14, no. 2, 22 May 2014 (2014-05-22), NZ, pages 125 - 132, XP055296575, ISSN: 1174-5886, DOI: 10.1007/s40268-014-0047-7
ref_type: npl
severity: background
ref_id: - BUSTER JOHN E: "Managing female sexual dysfunction", FERTILITY AND STERILITY, vol. 100, no. 4, October 2013 (2013-10-01), pages 905 - 915, XP028730023, ISSN: 0015-0282, DOI: 10.1016/J.FERTNSTERT.2013.08.026
ref_type: npl
severity: background
ref_id: WO2005107810
ref_type: patent
severity: background
ref_id: WO2012158030
ref_type: patent
severity: novelty_destroying
ref_id: - KIM VAN ROOIJ ET AL, "Pharmacokinetics of a Prototype Formulation of Sublingual Testosterone and a Buspirone Tablet, Versus an Advanced Combination Tablet of Testosterone and Buspirone in Healthy Premenopausal Women", DRUGS IN R & D, NZ, (20140522), vol. 14, no. 2, doi:10.1007/s40268-014-0047-7, ISSN 1174-5886, pages 125 - 132, XP055296575 [A] 1-13 * abstract * * page  127, column  1, paragraph  5  - column  2, paragraph  1 *
ref_type: npl
severity: background
ref_id: - BUSTER JOHN E, "Managing female sexual dysfunction", FERTILITY AND STERILITY, (201310), vol. 100, no. 4, doi:10.1016/J.FERTNSTERT.2013.08.026, ISSN 0015-0282, pages 905 - 915, XP028730023 [A] 1-13 * page  910, column  2, paragraph  4 *
ref_type: npl
severity: background
Final disposition: pending (2017-11-29)