Controlled release formulation (albuterol)
AssigneeEdward Mendell Co., Inc.
InventorsAnand Baichwal, Troy W. McCall
Life of this patent
Estimating the term…
Abstract
A sustained release pharmaceutical formulation and methods of making and using the same are provided. The sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional hydrophobic material and/or hydrophobic coating, and a medicament for sustained oral administration.
Claims16
A controlled release solid dosage form for oral administration of a therapeutically active medicament to a patient in need thereof, comprising:
- a pharmaceutically effective amount of a medicament to be administered to a patient in need of said medicament;
- a sustained release excipient comprising a gelling agent;
- a pharmaceutically acceptable hydrophobic material;
- and an inert pharmaceutical diluent wherein the ratio of said inert diluent to said gelling agent is from about 1:8 to about 8:1, said dosage form providing a sustained release of said medicament when exposed to an environmental fluid.
A method of preparing a controlled release solid dosage form comprising a medicament for oral administration, the method comprising
- preparing of a sustained release excipient comprising from about 10 to about 99 percent by weight of a gelling agent, from about 0 to about 89 percent by weight of an inert pharmaceutical diluent, and from about 1 to about 90 percent by weight of a pharmaceutically acceptable hydrophobic material;
- and
- adding a therapeutically effective amount of a medicament to said excipient, such that
- a final product is obtained having a ratio of said medicament to said gelling agent from about 1:3 to about 1:8, wherein said formulation provides therapeutically effective blood levels of said medicament for at least 12 hours.
A method of treating a patient with albuterol comprising:
- preparing a sustained release excipient comprising from about 10 to about 99 percent by weight of a gelling agent from about 0 to about 89 percent by weight of an inert pharmaceutical diluent, and from about 1 to 90 percent by weight of a pharmaceutically acceptable hydrophobic material;
- and
- adding an effective amount of albuterol or a salt or derivative thereof to said sustained release excipient, tableting the resultant mixture into tablets such that said tablets have a ratio of albuterol to said gelling agent from about 1:3 to about 1:8, such that a gel matrix is created when said tablet is exposed to gastrointestinal fluid and said tablet provides therapeutically effective blood levels of albuterol for at least 12 hours;
- and
- administering said tablet to a patient on a once-a-day or twice-a-day basis.
Dependencies are inferred from the claim text.