Abstract: The present invention contemplates a high dose finished pharmaceutical dosage form comprising colestipol hydrochloride in its commercially available form (i.e., beads) without the need for further milling. A manufacturing process used to manufacture the instant high dose finished pharmaceutical dosage form comprising colestipol hydrochloride, which monitors moisture content throughout the granulation process, is also disclosed herein.

Abstract: The present invention contemplates a high dose finished pharmaceutical dosage form comprising a methenamine salt, such as methenamine mandelate, as an active pharmaceutical ingredient wherein the methenamine salt API has a moisture content that is less than the upper limit specified in the USP. A preferred embodiment of the present invention has a moisture content that is half of the limit set forth in the USP for each particular methenamine salt. An even more preferred embodiment has a moisture content of less than or equal to one-tenth of a percent (0.1%), regardless of the methenamine salt. The present invention may include one or more pharmaceutically acceptable ingredients. The present invention also contemplates a moisture content of the high dose finished pharmaceutical dosage form that is less than one percent.

Abstract: The present invention contemplates a high dose finished pharmaceutical dosage form comprising a methenamine salt, such as methenamine mandelate, as an active pharmaceutical ingredient wherein the methenamine salt API has a moisture content that is less than the upper limit specified in the USP. A preferred embodiment of the present invention has a moisture content that is half of the limit set forth in the USP for each particular methenamine salt. An even more preferred embodiment has a moisture content of less than or equal to one-tenth of a percent (0.1%), regardless of the methenamine salt. The present invention may include one or more pharmaceutically acceptable ingredients. The present invention also contemplates a moisture content of the high dose finished pharmaceutical dosage form that is less than one percent.

Abstract: The present application discloses a finished pharmaceutical dosage form comprising a low dose/high potency active pharmaceutical ingredient and one or more excipients. The active pharmaceutical ingredient in the present application has been blended and subsequently milled with at least one excipient before preparing the finished pharmaceutical dosage form. The disclosed finished dosage form promotes content uniformity and acceptable and reproducible dissolution rate and extent. Finished dosage forms of the present invention may comprise any active pharmaceutical ingredient; however, low solubility and/or high potency active pharmaceutical ingredients will particularly benefit. Among the low solubility and/or high potency active pharmaceutical ingredients, those with needle-like structures are even more particularly well suited for incorporation into the disclosed finished dosage forms.