An efficient method for making high strength, highly porous, fast dissolving delivery devices. The method comprises mixing a formulation comprising menthol, a water-soluble, menthol-soluble polymer, and an active agent at a temperature such that the menthol is substantially molten. The formulation is disposed in a mold, solidified and the menthol is sublimed from the solidified molded formulation. Preferably, the solidification occurs at a temperature sufficient to provide a substantially amorphous menthol structure.
This application was filed under 35 U.S.C. .sctn.371 based on PCT/US92/09321, which was filed on Nov. 6, 1992 published as WO93/18757, sep. 30, 1993, which is a continuation of U.S. application Ser. No. 07/852,702 which was filed on Mar. 17, 1992 and is now abandoned.
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.
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.
The present invention is a process for forming a low density compression dosage unit to provide increased strength. The process of the present invention includes compacting under bi-level compaction pressure to provide a continuous-volume dosage unit which has a first volume defining an edge portion of the unit and a density which is greater than a density of a second volume defining a non-edge portion of the unit. The present invention also includes the product resulting from the process and apparatus used to make such units.
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 forming a solution or a suspension in a solvent of a form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension or solution and removing the solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable form of the pharmaceutically active substance is formed.
A method of producing a fast-dissolving pharmaceutical delivery device of moderate strength. The delivery device is a fully formed tablet composed of readily available sugars, strength polymers and a volatilizable excipient along with an active ingredient and optional flavorings. The tablet as made will disintegrate in an aqueous medium such as saliva in under 15 seconds, making mastication unnecessary or at least requiring only one or two bites on the tablet. Essential to the invention is the easily obtainable particle size ranges of the sugars and the volatilizable excipient which promotes optimum release and tablet strength. The invention also allows for effective taste masking of the active ingredient with standard particle coating techniques.
