INJECTION-MOLDED DOSAGE FORM

• US 20140271833A1
• Filed: 10/09/2012
• Published: 09/18/2014
• Est. Priority Date: 10/12/2011
• Status: Active Grant

• Current Assignee: Dow Global Technologies LLC (Dow, Inc.)
• Original Assignee: Dow Global Technologies LLC (Dow, Inc.)
• Inventors: Read, Michael D., Coppens, Karen A., Zhao, Jin, Hall, Mark J.
• Granted Patent: US 9,649,278 B2
• Time in Patent Office: Days
• US Class Current: 424/451
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61K 9/4883 Capsule finishing, e.g. dyeing, aromatising, polishing
• CPC Class Codes: C08K 5/0016 Plasticisers
• CPC Class Codes: C08K 5/05 Alcohols; Metal alcoholates
• CPC Class Codes: C08L 1/28 Alkyl ethers
• CPC Class Codes: C08L 1/286 substituted with acid radicals, e.g. carboxymethyl cellulose [CMC] C08L1/282 takes precedence
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00

Abstract

An injection-molded shell of a dosage form of good quality is producible by a) providing a composition comprising i) from 25 to 90 weight percent of ethylcellulose, ii) from 7.5 to 60 weight percent of a polysaccharide or polysaccharide derivative being different from ethylcellulose, and iii) from 2.5 to 50 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition, with the proviso that the composition comprises zero or not more than 10 weight percent of gelatin and zero or not more than 10 weight percent of a polymer comprising homo- or copolymerized acrylic acid, homo- or copolymerized methacrylic acid, a homo- or copolymerized acrylate or a homo- or copolymerized methacrylate, and b) subjecting the composition to shearing and heat to plasticize the composition and injection-molding the plasticized composition into a three-dimensional shell of a dosage form.

Claims

1. An injection-molded shell of a dosage form producible by

a) providing a composition comprising i) from 25 to 90 weight percent of ethylcellulose, ii) from 7.5 to 60 weight percent of a polysaccharide or polysaccharide derivative being different from ethylcellulose, and iii) from 2.5 to 50 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition, with the proviso that the composition comprises zero or not more than 10 weight percent of gelatin and zero or not more than 10 weight percent of a polymer comprising homo- or copolymerized acrylic acid, homo- or copolymerized methacrylic acid, a homo- or copolymerized acrylate or a homo- or copolymerized methacrylate, and

b) subjecting the composition to shearing and heat to plasticize the composition and injection-molding the plasticized composition into a three-dimensional shell of a dosage form.

2. The shell of claim 1 being a capsule shell.

3. The shell of claim 1 wherein the polysaccharide derivative ii) is a cellulose ether different from ethylcellulose.

4. The shell of claim 1 wherein the polysaccharide derivative ii) is a cellulose ether selected from the group consisting of methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl methylcellulose, ethylhydroxyethyl cellulose, hydroxypropyl cellulose, cross-linked carboxymethylcellulose, non-crosslinked carboxymethylcellulose, and combinations of two or more of these cellulose ethers.

5. The shell of claim 1 wherein the polysaccharide derivative ii) is methyl cellulose.

6. The shell of claim 1 comprising i) from 30 to 80 weight percent of ethylcellulose, ii) from 10 to 50 weight percent of a polysaccharide or polysaccharide derivative being different from ethylcellulose, and iii) from 10 to 40 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition.

7. The shell of claim 6 comprising i) from 35 to 70 weight percent of ethylcellulose, ii) from 15 to 50 weight percent of a polysaccharide or polysaccharide derivative being different from ethylcellulose, and iii) from 15 to 40 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition.

8. The shell of claim 7 comprising i) from 35 to 60 weight percent of ethylcellulose, ii) from 20 to 40 weight percent of methylcellulose, and iii) from 20 to 40 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition.

9. The shell of claim 1 wherein the composition does not comprise more than 15 percent of water or an organic solvent, based on the total weight of the composition.

10. The shell of claim 1 producible without pelletizing step between the plastification and the injection-molding step.

11. A dosage form comprising the shell of claim 1 and one or more active ingredients.

12. The dosage form of claim 11 wherein the shell is in the shape of a capsule body and a capsule cap welded or mechanically joined to the capsule body.

13. A method of manufacturing a shell of a dosage form comprising the steps of

a) providing a composition comprising i) from 25 to 90 weight percent of ethylcellulose, i] from 7.5 to 60 weight percent of a polysaccharide or polysaccharide derivative being different from ethylcellulose, and iii) from 2.5 to 50 weight percent of at least one component being different from polysaccharides and polysaccharide derivatives, based on the total weight of the composition, with the proviso that the composition comprises zero or not more than 10 weight percent of gelatin and zero or not more than 10 weight percent of a polymer comprising homo- or copolymerized acrylic acid, homo- or copolymerized methacrylic acid, a homo- or copolymerized acrylate or a homo- or copolymerized methacrylate, and

b) subjecting the composition to shearing and heat to plasticize the composition and injection-molding the plasticized composition into a three-dimensional shell of a dosage form.

14. The method of claim 13 wherein the plasticized composition is not subjected to a pelletizing step before injection-molding it into a shell of a dosage form.

15. The method of claim 13 wherein the composition is injection-molded into the shape of a capsule body and a capsule cap, one or more active ingredients and optional additives are filled into the capsule body and the capsule cap is welded or mechanically joined to the capsule body.