Fast-dispersing doses, which are designed to release the active ingredient in the oral cavity without water, are increasingly used by the pharmaceutical industry to deliver a wide range of drugs. Many such fast-dispersing dosage forms utilise gelatin as a carrier.
Gelatin BP, which is normally used in such formulations, is obtained by partial hydrolysis of animal collagenous tissues such as skin, tendons, ligaments and bones, with boiling water. However, such mammalian-derived gelatin has an unpleasant taste and thus necessitates the use of sweeteners and flavours in such fast-dispersing dosage forms to mask it, over and above any compounds used to mask the taste of the active ingredient.
Moreover, when conventional mammalian derived gelatin is used in the production of such fast-dispersing dosage forms, it is necessary to heat the gelatin solution to 60 degrees C in order for it to dissolve. This heating step increases processing times and increases the overall cost of the process.
RP Scherer's scientists have found that many of the problems associated with the use of mammalian-derived gelatin can be overcome if fish gelatin, and especially non-gelling fish gelatin, is used for preparing fast-dispersing dosage forms.
It has a more neutral taste, reducing the need for taste-masking, and also stays in solution at temperatures as low as 20 degrees C. This means that the gelatin and active ingredient can be mixed at a much lower temperature prior to freeze-drying.
"The pharmaceutical industry is constantly searching for improved dosage forms that are economical to produce and avoid problems associated with mammalian gelatin," said RP Scherer. "The dosage forms according to the present invention addresses these needs and do so with superior results," it added.
Companies which manufacture fish gelatin for pharmaceutical applications include Croda Colloids, Norland Products and Rousselot.