Pharmaceutical preparations in solid unit dosage form

• US 4,450,877 A
• Filed: 09/08/1982
• Issued: 05/29/1984
• Est. Priority Date: 11/03/1977
• Status: Expired due to Term

• Current Assignee: Aventis Pharma Deutschland GmbH (Sanofi )
• Original Assignee: Hoechst Aktiengesellschaft (Sanofi )
• Inventors: Walker, Stephen E., Eaves, Terence, Bedford, Keith
• Primary Examiner(s): Bell, Jr., Houston S.
• Application Number:
  US06/416,046
• Time in Patent Office: 629 Days
• Field of Search: 141/129-198, 141/250-284, 141/1-12, 141/37-96, 424/78, 424/81, 264/4, 53/266 R
• US Class Current: 141/1
• CPC Class Codes: A61J 3/074 Filling capsules; Related operations
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds

Abstract

A process for the manufacture of pharmaceutical preparations in hard capsule form and a capsule filling machine equipped with a detector system and a filling head suitable for dosing a liquid.

Claims

1. A process for the manufacture of a pharmaceutical preparation in unit dosage form, which comprises the steps of preparing a liquid carrier containing an active ingredient and a liquid which solidifies or gels sufficiently to lose its liquid flow properties said liquid carrier being a thixotropic gelling agent, and dosing said liquid carrier containing the active ingredient in its liquid form into a rigid shell suitable for administration as a dosage unit.

2. The process of claim 1, wherein the liquid carrier comprises a polyethylene glycol having a molecular weight in the range of from 1000 to 6000, a mixture of two or more such polyethylene glycols or a mixture of one or more such polyethyleneglycols with polyvinylacetate.

3. The process of claim 1, wherein the thixotropic gelling agent is hydrogenated castor oil or colloidal silicon dioxide.

4. The process of claim 1, wherein the rigid shell is the body of a hard gelatin capsule.

5. The process of claim 1, wherein the dosing takes place in a high-speed hard gelatin capsule filling machine.

6. The process defined in claim 1 wherein the liquid carrier containing the active ingredient is dosed into the rigid shell using a capsule filling machine which is equipped with a detector system and a filling head suitable for dosing a liquid.

7. The process defined in claim 1 wherein the liquid carrier containing the active ingredient is dosed into the rigid shell using a capsule filling machine which is equipped with a detector system and a refillable syringe, a peristaltic pump or a precision shot dispenser as filling head.

8. The process defined in claim 1 which comprises detecting the presence or absence of a shell to receive a dosage unit before dosing the shell with liquid carrier and active ingredient.

12. A pharmaceutical preparation in unit dosage form manufactured by the process defined by claim 1.

9. A process for the manufacture of a pharmaceutical preparation in unit dosage form, which comprises the steps of dispersing an active ingredient into a liquid carrier which is a thixotropic gelling agent and maintained in its liquid form, dosing said liquid carrier containing the active ingredient into a rigid shell suitable for administration as a dosage unit, and thereafter permitting said carrier in said shell to solidify.

10. The process of claim 18, wherein the liquid carrier comprises a polyethylene glycol having a molecular weight in the range of from 1000 to 6000, a mixture of two or more such polyethylene glycols or a mixture of one or more such polyethyleneglycols with polyvinylacetate.

11. The process of claim 18, wherein the thixotropic gelling agent is hydrogenated castor oil or colloidal silicon dioxide.