Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1996-03-26
1998-10-06
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424441, 424451, 424484, 424488, 514774, 514777, 514778, A61K 920, A61K 948
Patent
active
058173234
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/GB94/01361 filed Jun. 23, 1994.
This invention relates to compositions for the use in comestible and other soft gelatin capsules, of the type used in oral drug delivery systems and in food products and food additives.
It is known to encapsulate medicinal and food products using capsule material which is itself comestible. The shell material for such capsules is normally gelatin based, and as a consequence largely void of flavour, odour and colour. While such capsules have been used with great success, gelatin based shell materials can be relatively slow in disintegrating, and particularly where an encapsulated product for oral use is intended to be released in the mouth, faster disintegration rates are desirable.
Examples of gelatin based capsules are described in the following Patent Specifications to which reference is directed:
Shell materials of the above type normally comprise Gelatin and a physiologically acceptable plasticiser such as Glycerol, the Gelatin forming a matrix for the plasticiser. The relative quantities of these components is important to ensure reliable encapsulation, and storage characteristics. However, we have found that the amount of Gelatin can be reduced if a further component is included which forms a secondary matrix for the plasticiser. According to the invention therefore, a composition for use in the shell of a capsule comprises Gelatin and a plasticiser, the Gelatin forming a primary matrix for the plasticiser; and a further component compatible with the Gelatin, which component forms a secondary matrix for the plasticiser. Typically, the composition includes 18 to 30% by weight of Gelatin and 30 to 45% by weight of the plasticiser. The further component is normally a potato starch acetate, another starch derivative, starch itself or mixtures thereof.
The invention also provides chewable compositions formulated according to the above criteria, and comestible capsules with shells comprising such compositions. Additionally disclosed herein is a process for the preparation of a composition according to the invention comprising the steps of mixing the further component with water and the plasticiser; adding the gelatin to the mixture; allowing the mixture to crumb; heating the mixture; leaving the heated mass to stand; and deaerating the mass with minimum water loss.
In preferred compositions according to the invention the amount of the further component does not exceed 25%, and is normally no more than 12% by weight. The preferred further component is unbleached starch acetate, most preferably derived from potato, and a suitable product is available under the Trade Name PERFECTAMYL GEL MB from Avebe BA. Another suitable potato starch acetate is available from Roquette Freres, under the Trade Name CLEARAM.
A typical amount of the further component is up to 12% by weight. While higher levels result in a more chewable product, solubility is likely to deteriorate. Additionally, examination of capsules formed from selected compositions using higher levels of starch acetate as the further component, showed that some starch aggregation was taking place. A preferred maximum level is 10%; 8% is particularly preferred.
The quantities of gelatin specified above are substantially less than is normally used in known gelatin based capsule shell compositions. Similarly, the amount of plasticiser is relatively increased. This is made possible by the presence of the further component which reduces the effect of the plasticiser on the gelatin which might otherwise result in a composition which does not form a structure of strength sufficient for encapsulation and storage. In effect, the further component forms a secondary compatible matrix, typically in the range 20.degree. to 60.degree. C., for the plasticiser within the primary gelatin matrix which does not adversely effect the function of the plasticiser, but reduces its tendency to form an adherent surface on the eventual product. It will be appreciated that a certain quantity of the further component is al
REFERENCES:
patent: 4935243 (1990-06-01), Borkan et al.
Fischer Gerhard
Garnett Kelvin Royce
Hutchinson Keith Graeme
Page Nicola Sandra
Page Thurman K.
R.P. Scherer Corporation
Spear James M.
LandOfFree
Soft gelatin capsule shell compositions does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Soft gelatin capsule shell compositions, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Soft gelatin capsule shell compositions will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-74576