Finished pharmaceutical dosage form of a methenamine salt such as methenamine mandelate
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.
1. A high dose finished pharmaceutical dosage form comprising methenamine mandelate as an active pharmaceutical ingredient wherein the methenamine mandelate active pharmaceutical ingredient has a moisture content of no more than one-tenth of a percent and wherein the high dose finished pharmaceutical dosage form has a total moisture content of less than one percent.
2. A high dose finished pharmaceutical dosage form of claim 1 wherein the high dose finished pharmaceutical dosage form is a tablet.
3. A high dose finished pharmaceutical dosage form comprising at least one pharmaceutically acceptable excipient and methenamine mandelate as an active pharmaceutical ingredient wherein the methenamine mandelate active pharmaceutical ingredient has a moisture content of no more than one-tenth of a percent and wherein the high dose finished pharmaceutical dosage form has a total moisture content of less than one percent.
4. A high dose finished pharmaceutical dosage form of claim 3 wherein the high dose finished pharmaceutical dosage form is a tablet.
5. A high dose finished pharmaceutical dosage form of claim 3 wherein the pharmaceutically acceptable excipient is a binder.
6. A high dose finished pharmaceutical dosage form of claim 3 wherein the pharmaceutically acceptable excipient is a lubricant.
7. A high dose finished pharmaceutical dosage form of claim 3 wherein the pharmaceutically acceptable excipient is a binder or a lubricant.
8. A high dose finished pharmaceutical dosage form of claim 3 wherein the pharmaceutically acceptable excipient is a binder or a lubricant and wherein the high dose finished pharmaceutical dosage form is a tablet.