Source: https://patents.google.com/patent/US8383159
Timestamp: 2018-03-22 10:18:40
Document Index: 154519940

Matched Legal Cases: ['Application No. 60', 'art 520', 'art 520', 'art 520', 'art 520', 'art 520']

US8383159B2 - Dosage forms having a microreliefed surface and methods and apparatus for their production - Google Patents
Dosage forms having a microreliefed surface and methods and apparatus for their production Download PDF
US8383159B2
US8383159B2 US11236038 US23603805A US8383159B2 US 8383159 B2 US8383159 B2 US 8383159B2 US 11236038 US11236038 US 11236038 US 23603805 A US23603805 A US 23603805A US 8383159 B2 US8383159 B2 US 8383159B2
US11236038
US20060088585A1 (en )
This Application claims the benefit of U.S. Application No. 60/622,666 filed on 27 Oct. 2004, which is incorporated by reference in its entirety herein.
FIG. 4D is an enlarged, cross-sectional view of the injector port/cavity interface of the injection molding apparatus of FIG. 4A.
FIG. 13B is an enlarged, simplified perspective view of the dosage form resulting from covering the dosage form of FIG. 13A with the additional film of FIG. 13A to yield a dosage form having a Moiré effect.
In one embodiment, the refractive index of the topcoat is not equivalent to the refractive index of the core. The topcoat may also be clear or semi-transparent in
FIGS. 2A and 2B depict another embodiment of this invention. FIG. 2A depicts a dosage form 102 that comprises a core 104. The core has a shell 105 residing on at least a portion of the exterior surface of core 104. The shell 105 is shown in greater detail in FIG. 2B, which is a cross-sectional view of the dosage form of FIG. 2A. As shown in FIG. 2B, the shell 105 residing on the exterior surfaces 108 and 110 of core 104 comprises a first shell portion 107 having cavities, with molded inlaid second shell portions 106 residing in the cavities. At least one of the inlaid second shell portions 106 possesses micrographs 111. These micrographs may protrude from, be substantially uniform with, or be recessed from the proximate shell portion exterior surface 107′. In this embodiment, a first active ingredient may be located within shell portion 107 and a second active ingredient may be located within inlaid second shell portions 106, although in other embodiments only one of first shell portion 107 or inlaid second shell portions 106 may contain an active ingredient. Core 104 may optionally also contain an active ingredient, which may be the same or different than the active ingredient contained in first shell portion 107 and inlaid second shell portions 106.
One suitable hydroxypropylmethylcellulose compound is HPMC 2910, which is a cellulose ether having a degree of substitution of about 1.9 and a hydroxypropyl molar substitution of 0.23, and containing, based upon the total weight of the compound, from about 29% to about 30% methoxyl groups and from about 7% to about 12% hydroxylpropyl groups. HPMC 2910 is commercially available from the Dow Chemical Company under the tradename, “METHOCEL E.” METHOCEL E5, which is one grade of HPMC-2910 suitable for use in the present invention, has a viscosity of about 4 to 6 cps (4 to 6 millipascal-seconds) at 20° C. in a 2% aqueous solution as determined by a Ubbelohde viscometer. Similarly, METHOCEL E6, which is another grade of HPMC-2910 suitable for use in the present invention, has a viscosity of about 5 to 7 cps (5 to 7 millipascal-seconds) at 20° C. in a 2% aqueous solution as determined by a Ubbelohde viscometer. METHOCEL E15, which is another grade of HPMC-2910 suitable for use in the present invention, has a viscosity of about 15000 cps (15 millipascal-seconds) at 20° C. in a 2% aqueous solution as determined by a Ubbelohde viscometer.
As used herein, “degree of substitution” shall mean the average number of substituent groups attached to a anhydroglucose ring, and “hydroxypropyl molar substitution” shall mean the number of moles of hydroxypropyl per mole anhydroglucose.
Suitable xanthan gums include those available from C. P. Kelco Company under the tradenames, “KELTROL 1000,” “XANTROL 180,” or “K9B310.”
In embodiments when the cavity is filled with gelatin, and the gelatin portion contains a microrelief, the gelatin generally shrinks vertically, e.g., by about 50% to about 75% and laterally, e.g., by about 1% to about 10%. In order to compensate for this shrinkage, the diffractive relief pattern molded into the wet gelatin is sized to be about 50% to about 75% larger in the vertical dimension and about 1% to about 10% larger in the horizontal dimension than the dimensions of the pattern in the final dried dosage form product. Therefore, for example, if the final product has a diffractive grating of about 500 lines or grooves per millimeter, the diffractive pattern etched into the surface of the mold would be a negative pattern and have about 476 lines or grooves per millimeter. Likewise in the vertical dimension, if the linear ridges making up the diffractive grating of the final, dried dosage form product are about ⅔ microns in height, then the diffractive pattern etched into the surface of the mold would be a negative pattern and have about 3 times the vertical dimension of the grating in the dried, finished product or approximately 2 microns.
In an alternative embodiment shown in FIGS. 6A and 6D, a removable change-part 520,520′ such as a thin film or foil, containing the desired microrelief 512 may be inserted on to the internal surface 506′ of the upper mold, or in the internal surface of one of the dies used in a tablet press, via any known means for removably attaching the change-part such as, for example adhesives. In alternative embodiment shown in FIG. 6B and FIG. 6C, respectively, the removable change-part 520 may extend across the entire internal surface 506′ of the upper mold 506 (see changepart 520″ in FIG. 6B), or may be friction-fit into an opening in the upper mold 506 (see changepart 520′″ in FIG. 6C). Advantageously, the changepart 520 used in this embodiment could easily be removed and replaced with another changepart having an alternative microrelief pattern with minimal cost and production cycle time loss.
In one embodiment, the inlaid portion may be substantially free of pores having a diameter of about 0.5 microns to about 5 microns. As used herein, “substantially free” means that the inlaid portion has a pore volume of less than about 0.02 cc/g, e.g. less than about 0.01 cc/g or less than about 0.005 cc/g, in the pore diameter range of about 0.5 microns to about 5 microns. Typical compressed materials have pore volumes of more than about 0.02 cc/g in this pore diameter range. Pore volume, pore diameter and density may be determined using a Quantachrome Instruments PoreMaster 60 mercury intrusion porosimeter and associated computer software program known as “Porowin.” The procedure is documented in the Quantachrome Instruments PoreMaster Operation Manual. The PoreMaster determines both pore volume and pore diameter of a solid or powder by forced intrusion of a non-wetting liquid (mercury), which involves evacuation of the sample in a sample cell (penetrometer), filling the cell with mercury to surround the sample with mercury, applying pressure to the sample cell by: (i) compressed air (up to 50 psi maximum); and (ii) a hydraulic (oil) pressure generator (up to 60000 psi maximum). Intruded volume is measured by a change in the capacitance as mercury moves from outside the sample into its pores under applied pressure. The corresponding pore size diameter (d) at which the intrusion takes place is calculated directly from the so-called “Washburn Equation”: d=−(4γ(cosθ))/P where γ is the surface tension of liquid mercury, θ is the contact angle between mercury and the sample surface and P is the applied pressure.
A macrorelief—containing coating may be applied to the striped core surface in a manner similar to those disclosed herein for applying a microreliefed coating to cores. Examples of suitable coatings include, but are not limited to, those comprising gelatin, methacrylic acid and methacrylate ester copolymers, polyvinylpyrrolidone, cellulose acetate, HPMC, polyethylene oxide and polyvinylalcohol copolymers, ethylcellulose, polyvinyl alcohols, and derivatives, and copolymers and mixtures thereof. As a result, when light passes through the lenticules 920 of a microrelief coating on a core 921 as illustrated in FIG. 11, it is reflected from an underlying surface, i.e., e.g., the tablet surface that contains printed information or an image. The lenticule refracts the returning light and magnifies the underlying information or image. The information or image, which underlies the lenticules and is arranged in stripes 902, 903, is appropriately aligned so that all of the stripes for particular information/image are refracted to the same point in order to create a single image. As the orientation of the lenticular surface is changed in relation to the line of sight by an observer, different image stripes can then be seen as complete images. FIG. 11 illustrates a dosage form having the appearance of two different colors. The dosage form may appear to be one color (FIG. 11A) based upon the refraction of light from a first set of strips 902, and a second color (FIG. 11C) based upon the refraction of light from a second set of strips 903 after the orientation of the lenticular surface is changed.
In another embodiment as illustrated in FIG. 12, the surface of the dosage form may either have the appearance of the term, “500,” or alternatively the term, “TYLENOL.” As shown in FIGS. 12A and 12D, each of these two terms may be divided into a plurality of strips. The strips are then arranged in an alternating manner to form strip pairs 901 on the surface of the core 921. When an observer directly looks down upon the top surface of the resulting dosage form, the dosage form may have the appearance as shown in FIG. 12E. However, as the orientation of the lenticular surface 920 is changed in relation to the line of sight by an observer, the different image stripes can then be seen as one of two complete images, i.e., e.g., as either the “500” (FIG. 12C) or the “TYLENOL” (FIG. 12B).
Acetaminophen tablets having the formula set forth in Table A below are compressed on a rotary tablet press. The tablet press is equipped with compression tooling that is designed to deboss the upper surface of the pressed tablet with the letter “Y.” See FIGS. 5A and 5B. The compression tooling is keyed such that the orientation of the debossed lettering is the same for all tablets and is in proper alignment with the molding cavities of the injection molding apparatus.
Example 3 Coated, Compressed Acetaminophen Core having a Surface Microrelief
A. Method for Preparing Microrelief Films Via Solution Casting:
1. A dosage form comprised of:
a) a core, wherein the core comprises a pharmaceutically active agent; and
b) an outer layer comprised of a carrier and the composition comprised of polymeric film flakes having at least one surface wherein the polymeric film flakes possess a microrelief on the at least one surface and wherein the microrelief is a high resolution diffraction grating or dovid.
2. The dosage form of claim 1, wherein the outer layer is further comprised of a polymeric matrix containing at least one polymer in a substantially amorphous form.
3. The dosage form of claim 1, wherein the core further comprises a pharmaceutically active agent.
4. The dosage form of claim 1, wherein the microrelief is a high resolution diffraction grating.
5. The dosage form of claim 1, wherein the microrelief is a dovid.
6. The dosage form of claim 2, wherein the core further comprises a pharmaceutically active agent.
7. The dosage form of claim 2, wherein the microrelief is a high resolution diffraction grating.
8. The dosage form of claim 3, wherein the microrelief is a high resolution diffraction grating.
9. The dosage form of claim 6, wherein the microrelief is a high resolution diffraction grating.
10. The dosage form of claim 2, wherein the microrelief is a dovid.
11. The dosage form of claim 3, wherein the microrelief is a dovid.
12. The dosage form of claim 6, wherein the microrelief is a dovid.
13. The dosage form of claim 5, wherein the dovid is a hologram.
14. The dosage form of claim 10, wherein the dovid is a hologram.
15. The dosage form of claim 11, wherein the dovid is a hologram.
16. The dosage form of claim 12, wherein the dovid is a hologram.
17. The dosage form of claim 13, wherein the dovid is a hologram.
US11236038 2004-10-27 2005-09-27 Dosage forms having a microreliefed surface and methods and apparatus for their production Active 2029-05-21 US8383159B2 (en)
US62266604 true 2004-10-27 2004-10-27
US11236038 US8383159B2 (en) 2004-10-27 2005-09-27 Dosage forms having a microreliefed surface and methods and apparatus for their production
DE200560018529 DE602005018529D1 (en) 2004-10-27 2005-10-26 Dosage forms with a micro-relief surface and process and device for its manufacture
JP2007539123A JP2008518030A (en) 2004-10-27 2005-10-26 METHOD AND APPARATUS FOR microrelief surface with the dosage forms and of making such dosage forms
PCT/US2005/038799 WO2006047692A3 (en) 2004-10-27 2005-10-26 Dosage forms having a microreliefed surface and methods and apparatus for their production
EP20050819867 EP1811968B1 (en) 2004-10-27 2005-10-26 Dosage forms having a microreliefed surface and methods and apparatus for their production
CA 2587087 CA2587087A1 (en) 2004-10-27 2005-10-26 Dosage forms having a microreliefed surface and methods and apparatus for their production
US20060088585A1 true US20060088585A1 (en) 2006-04-27
US8383159B2 true US8383159B2 (en) 2013-02-26
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US11236038 Active 2029-05-21 US8383159B2 (en) 2004-10-27 2005-09-27 Dosage forms having a microreliefed surface and methods and apparatus for their production
US (1) US8383159B2 (en)
EP (1) EP1811968B1 (en)
JP (1) JP2008518030A (en)
CA (1) CA2587087A1 (en)
DE (1) DE602005018529D1 (en)
WO (1) WO2006047692A3 (en)
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