R.p. Scherer Corporation

R.p.scherer Technologies, Inc.

Richard David Green

Patrick Kearney

Michael Hall

Leon Grother

Edward Stewart Johnson

Owen Murray

Anthony Clarke

Douglas Bryans

Owen James Murray

The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is fish gelatin and the composition is a fast-dispersing dosage form designed to release the active ingredient rapidly on contact with a fluid. In one embodiment, the composition is designed for oral administration and releases the active ingredient rapidly in the oral cavity on contact with saliva. The fish gelatin can be obtained from cold water fish sources and is preferably the non-gelling, non-hydrolyzed form. A process for preparing such a composition and a method of using fish gelatin in a fast dispersing dosage form are also provided.

Fast-dispersing dosage forms containing fish gelatin

The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90% by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.

Fast dispersing dosage forms essentially free of mammalian gelatin

This invention is directed to an oral solid, rapidly disintegrating, freeze-dried dosage form containing coarse particles of a pharmaceutically active material which are uncoated or coated with a polymer or lipid material. Preferably, the oral dosage form comprises coarse particles having a size in the range of 50 micron to 400 micron. The oral solid rapidly disintegrating dosage form according to the present invention preferably disintegrates in the oral cavity in less than 10 seconds.

Fast-Dispersing solid oral dosage form containing coarse particles

The use of a pharmaceutical composition for oral administration comprising a carrier and active ingredient selected from a dopamine agonist, testosterone and mixtures thereof, the composition being in the form of a fast-dispersing dosage form designed to release the active ingredient rapidly in the oral cavity for the manufacture of a medicament for treatment of male erectile dysfunction.

Image forms and method for ameliorating male erectile dysfunction

In one embodiment, this invention relates to a pharmaceutical composition for oral administration consisting essentially of a gelatin at a concentration up to 5% by weight as a carrier, a solvent, and, as an active ingredient, a dopamine agonist. Alternatively, the invention relates to a composition that takes the form of a solid, unitary fast-dispersing dosage form comprised of a network of an active ingredient after and a water-soluble or water dispersible matrix forming agent or carrier which is inert towards the active ingredient after subliming solvent from the composition in the solid state. The dosage is designed to completely disintegrate within 1 to 30 seconds of being placed in the oral cavity. Compositions which further comprise an anti-emetic and/or an opioid antagonist are also provided herein.

Fast-dissolving dosage forms for dopamine agonists

This invention relates to a process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste which process comprises: (i) forming a solution or a suspension in a solvent of a water soluble or water dispersible carrier, a filler and the pharmaceutically active substance with the unacceptable taste in association with a lipid, the weight ratio of the pharmaceutically active substance to the lipid being in the range of from 1:1 to 1:10 and the weight ratio of the carrier to the lipid being in the range of from 5:1 to 1:15; (ii) forming discrete units of the suspension or solution; and (iii) removing the solvent from the discrete units under conditions whereby unit dosages are formed comprising a network of carrier/filler carrying a dosage of the pharmaceutically active substance in association with the lipid; oral solid rapidly disintegrating dosage forms prepared by such a process are also provided.

Process for preparing solid pharmaceutical dosage forms

Process is provided for preparing an oral solid rapidly disintegrating freeze-dried dosage form of a pharmaceutically active substance having an unacceptable taste, wherein prior to freeze drying, a suspension of uncoated or coated coarse particles of a pharmaceutically active substance in a carrier material is cooled to reduce the viscosity and minimize release of the active substance during processing, as well as beyond the point of disintegration of the form in the mouth, to minimize bad taste from the drug.

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Marlborough, United Kingdom

Richard David Green