Enteric capsules

• US 4,138,013 A
• Filed: 06/13/1977
• Issued: 02/06/1979
• Est. Priority Date: 08/27/1976
• Status: Expired due to Term

• Current Assignee: Parke Davis and Co (Pfizer Inc.)
• Original Assignee: Parke Davis and Co (Pfizer Inc.)
• Inventors: Okajima, Yakutaro
• Primary Examiner(s): Hayes, Lorenzo B.
• Application Number:
  US05/805,763
• Time in Patent Office: 603 Days
• Field of Search: 424/32, 424/33, 424/35, 424/37, 260/8, 220/8, 220/352, 427/3, 206/528, 206/529, 106/128, 106/137, 106/196, 106/189, 106/193 D, 106/197 R
• US Class Current: 206/528
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: Y10S 220/34 Anti-tamper pharmaceutical capsules, e.g. tamper indicating or resistant

Abstract

Pharmaceutical capsules with telescopically engaged body and cap portions, also known as hard shell capsules, having enteric properties. The capsule body and cap portions are formed by dip-molding using a homogeneous film-forming mixture comprising (1) hydroxypropyl methylcellulose and an ammonium salt of cellulose acetate phthalate polymer, or (2) gelatin and an ammonium salt of a copolymer of methacrylic acid and methacrylic acid alkyl ester; optionally with the inclusion of plasticizer and/or coloring agent. The capsules are soluble in or disintegrated by the alkaline intestinal secretions but are substantially insoluble or resistant to solution in the acid secretions of the stomach.

Claims

1. A hard-shell pharmaceutical capsule comprising telescopically engaged body and cap portions having enteric properties, being characterized by relative freedom from brittleness and by substantial absence of degradation on exposure to artificial gastric juice for 120 minutes, and the body and cap portions being formed by the dip-moldng technique from a homogeneous film-forming composition comprising a member of the group consisting of

(1) hydroxypropyl methylcellulose and an ammonium salt of cellulose acetate phthalate polymer, and

(2) gelatin and an ammonium salt of a copolymer of methacrylic acid and methacrylic acid ester,

the capsule having the proportion of 5 parts by weight of the ammonium salt, measured as free acid form, to 1 to 5 parts by weight of the gelatin or hydroxypropyl methylcellulose.

2. A pharmaceutical capsule according to claim 1 and containing up to 5% of glycerine.

3. A pharmaceutical capsule according to claim 1 and containing a coloring agent.

4. A pharmaceutical capsule according to claim 1 and containing up to 5% of propylene glycol.

5. A pharmaceutical capsule according to claim 1 formed from a homogeneous composition comprising hydroxypropyl methylcellulose and an ammonium salt of cellulose acetate phthalate polymer.

6. A pharmaceutical capsule according to claim 1 formed from a homogeneous composition comprising gelatin and an ammonium salt of a copolymer of methacrylic acid and methacrylic acid ester.