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Process for preparing pharmaceutical compositions for use with soft gelatin formulations

A technology of composition and filling composition, which is applied in the direction of drug combination, pharmaceutical formula, antipyretic, etc., can solve the problems such as difficult to complete, increase the dissociation of capsule shell, etc., and achieve economical production method, storage capacity and storage capacity Effects of time improvement and degradation reduction

Inactive Publication Date: 2004-02-25
R P SCHERER TECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Increasing the active ingredient concentration in a softgel dosage form and / or unit without increasing the total fill volume (thus increasing the overall size of the dosage form), and / or without increasing the dissociative properties of the capsule shell is technically proven to be very Difficult to complete
Also how to maintain the effective viscosity in the above method is also a problem

Method used

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Examples

Experimental program
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Embodiment 1

[0039] COMPARISON OF PROCESSES FOR PREPARING FILL COMPOSITIONS CONTAINING IBUPROFEN

[0040] Two pharmaceutical compositions suitable for soft capsules were prepared according to two different methods. One method was carried out according to previously known procedures (method 1), while the second method was carried out according to the present invention (method 2). The compositions prepared by the two methods (respectively preparations 1 and 2) all use ibuprofen as a pharmaceutically active ingredient and are suitable for soft capsule dosage form.

[0041] Method 1 proceeds as follows:

[0042] Begin by adding 20.4 kg of polyethylene glycol 600 to a heated mixing vessel and stir until the temperature drops to 35°C or less. Add 19.6 kg of ibuprofen to the container of polyethylene glycol 600. Blend the mixture to form a slurry. Afterwards, slowly add 5kg potassium hydroxide solution (potassium hydroxide accounts for 50% of gross weight, water accounts for 50%) to f...

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Abstract

The invention disclosed herein is a process for increasing the achievable concentration of a pharmaceutically active ingredient relative to fill composition viscosity for dosage units. The process is particularly useful in the preparation of soft gelatin capsules containing ibuprofen, naproxen, indomethacin, and acetaminophen, as the pharmaceutically active ingredient. As a result of the process, lesser quantities of composition ingredients other than the pharmaceutically active ingredient are needed to accomplish the same therapeutically effective dosage, thereby significantly increasing the concentration of the pharmaceutically active ingredient resulting in either a reduction in overall fill volume and dosage unit size or an increase in concentration of pharmaceutically active ingredient per dosage form.

Description

[0001] related application [0002] This application claims priority to US Application No. 09 / 649,947, filed August 29,2000. technical field [0003] The invention presented here relates to the field of oral pharmaceutical preparations. In particular, the present invention relates to an improved method for preparing the pharmaceutical composition required for the synthesis of soft capsules. The methods of the invention allow a given dose of active ingredient to be placed in a smaller dosage form. Background technique [0004] Solid one-piece softgels have been known and widely used for a variety of purposes for many years. Because soft capsules have characteristics different from traditional sleeve-type split-type hard capsules, soft capsules can preserve liquid filling substances. Soft capsules are generally used to preserve oral substances, such as vitamins and pharmaceutical compositions with liquid as a medium or carrier. [0005] In general, not all liquids are suit...

Claims

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Application Information

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IPC IPC(8): A61K47/34A61K9/48A61K31/167A61K31/192A61K31/405A61K45/00A61K47/02
CPCA61K9/4858A61K9/485A61P29/00A61K9/48
Inventor S·C·廷德尔C·C·韦伯斯特J·C·费迪南多J·C·刘易斯
Owner R P SCHERER TECH INC
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