Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1997-01-09
1998-09-29
Schofer, Joseph L.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424451, 424456, 424463, 424488, A61K 948
Patent
active
058143386
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a unit dosage drug delivery system in the form of a soft capsule of different size, shape and colour, consisting of an external capsule housing having two or more coupled layers, sheaths or films, made from different materials, and of a capsule filling having one or more pharmacologically active drug substances for oral, rectal or vaginal administration, which are admixed, dissolved, suspended or agglomerated in an hydrophobic support, consisting basically of the main suspending agent "silicone resin" and optionally of one or more physiologically acceptable auxiliary ingredients, alike surfactants, disaggregants, linear or ramified aliphatic C.sub.2 -C.sub.3 alcohols and their esters, retarding agents or other optional components, and to said pharmaceutical composition resulting thereof and to its method of preparation.
BACKGROUND OF THE INVENTION
Many attempts have been made in the past years to produce pharmaceutical forms, including some type of gelatin capsules and gelloids of gelatin, aiming to incorporate drug substances in the capsule filling, but the protection of the active ingredient has not been satisfactorily solved in case the used drug substance is degradable or unstable in presence of moisture, oxidizing agents or gastric (acid) fluid. Different types of gelatin capsules (hard or soft) have been studied by many authors, aiming to mainly protect the active ingredient against the atmosphere, but the results were partially satisfactory. A comprehensive review of different types of soft gelatin capsules has been reported by J. P. Stanley, Part II--Soft Gelatin Capsules of "The Theory and Practice of Industrial Pharmacy", pages 404-420, Edition Lea & Fabiger (Philadelphia), 1976 and by Casadio, "Tecnologia Farmaceutica", pages 705-707, Edition Cisalpino Gogliardica (Milan), 1972. Other authors have described conventional gelatin capsules in various patents as for example: U.S. Pat. Nos. 4,816,259; 3,656,997; 4,690,823; 5,173,304; 3,959,540; 3,432,594.
Described capsule housing conventionally possesses an external shell of which the basic ingredient is gelatin, and in general such capsule may be presented as either hard or soft gelatin capsule, the latter one containing suitable plasticizers. The shell of the conventional gelatin capsules consists of an unique external layer, having uniform composition and thickness, surrounding a capsule filling, which contains the pharmaceutical active drug substance admixed with suitable excipients. Few cases of an external film-coating layer have been also described. The unique external layer of the capsule shell of a conventional soft gelatin capsule contains basically gelatin, but also appreciable quantities of water as ingredient. However the presence of a certain amount of water in the conventional soft gelatin capsule housing constitutes a considerable seeking to formulate drugs or their salts, which are soluble in water or degradable in presence of moisture, or from the simple contact with water. In fact, by using the current ingredients and the known production techniques for conventional soft gelatin capsules, it is almost impossible to avoid the contact of the active drug substance, contained in the capsule filling, with the moisture of the gelatin mass of the external shell layer, either during the production steps or during the storage period of the finished capsule, until used for its intended purpose. Moreover, since the shell of the current soft gelatin capsules is containing, in addition to water, also large quantities of plasticizers (glycerol or sugars), conventional additives, including plasticizers, colouring agents, opacifiers and preserving agents, it is also difficult to satisfactorily prevent or to control possible chemical incompatibilities between the active drug substance incorporated in the filling and the ingredients of the capsule housing. Said ingredients may also enhance oxidation, degradation or hydrolysis processes, causing partial or sometime considerable loss of activity of the formulated a
REFERENCES:
patent: 3432594 (1969-03-01), Bauer
patent: 3656997 (1972-04-01), Cordes
patent: 3959540 (1976-05-01), Leiberich et al.
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patent: 5173304 (1992-12-01), Lohner et al.
patent: 5232704 (1993-08-01), Franz et al.
J. P. Stanley, Part II--Soft Gelatin Capsules of "The Theory and Practice of Industrial Pharmacy", pp. 404-420, Edition Lea & Fabiger (Philadelphia), 1976.
Casadio, "Tecnologia Farmaceutica", pp. 705-707, Edition Cisalpino Gogliardica (Milan), 1972.
Schofer Joseph L.
Shelborne Kathryne E.
Shurtz Steven P.
Therapicon S.R.L.
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