Oral Transmucosal Nicotine Dosage Form
AssigneesCephalon, Inc., Cima Labs Inc.
InventorsVikas Agarwal, Brian I. Hague, Rajendra K. Khankari
Life of this patent
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Abstract
Described herein are oral transmucosal solid dosage forms useful in treating nicotine addiction or as a nicotine substitute or replacement. By virtue of the formulation in combination with nicotine, the dosage forms transmucosally delivers an effective amount of nicotine to the recipient while permitting the accomplishing of such, and manufacture of such, using a relatively small, convenient and orally comfortable dosage form (e.g., tablet) size.
Claims26
A solid oral transmucosal dosage form comprising:
- a) nicotine or a nicotine derivative or a pharmaceutically acceptable salts thereof,
- b) an effervescent system;
- and
- c) a pH adjusting substance;
- the dosage form being formulated for resident placement within a recipient's oral cavity for transmucosal delivery of the nicotine or nicotine derivative across the recipient's oral mucosal tissue.
A solid oral transmucosal dosage form comprising the following ingredients:
- a) nicotine or nicotine derivative or a pharmaceutically acceptable salts thereof, and
- b) an effervescent system consisting essentially of an acid and an alkali metal or alkaline metal bicarbonate or carbonate salt;
- the dosage form being formulated for resident placement within a recipient's oral cavity for transmucosal delivery of the nicotine or nicotine derivative across the recipient's oral mucosal tissue;
- wherein the bicarbonate or carbonate salt is present in stoichiometric excess relative to the acid and the stoichiometric excess is sufficient to provide a localized pH in the range of about 4 to about 10.
A method of treating nicotine addiction in a recipient desiring such treatment, the method comprising:
- a) providing to the recipient a solid oral transmucosal dosage form comprising:
- i) nicotine or nicotine derivative or a pharmaceutically acceptable salts thereof,
- ii) an effervescent system;
- and
- iii) a pH adjusting substance;
- the dosage form being formulated for resident placement within a recipient's oral cavity for transmucosal delivery of the nicotine or nicotine derivative across the recipient's oral mucosal tissue;
- b) positioning the dosage form within the recipient's oral cavity adjacent to oral mucosal tissue;
- and
- c) permitting the dosage form to reside in such position for a period of time sufficient to permit the nicotine or nicotine derivative to transport across the oral mucosal tissue;
- wherein step c) provides a Cmax to dose ratio in a range of from about 3 to about 12 picogram/mL/microgram.
An oral transmucosal nicotine delivery system, the system comprising:
- a) a solid oral transmucosal dosage form comprising a composition comprising the following ingredients:
- i) nicotine or nicotine derivative or a pharmaceutically acceptable salt thereof,
- ii) an effervescent system;
- and
- iii) a pH adjusting substance;
- the dosage form being formulated for placement within a recipient's oral cavity for transmucosal delivery of the nicotine or nicotine derivative across the recipient's oral mucosal tissue;
- in combination with
- b) a holder;
- the dosage form being coupled to an end of the holder.
A method of nicotine substitution comprising:
- a) providing a dosage form to a recipient desiring the substitution, the dosage form being a solid oral transmucosal dosage form comprising:
- i) nicotine or nicotine derivative or a pharmaceutically acceptable salt thereof,
- ii) an effervescent system;
- and
- iii) a pH adjusting substance;
- the dosage form being formulated for placement within a recipient's oral cavity for transmucosal delivery of the nicotine or nicotine derivative across the recipient's oral mucosal tissue;
- b) placing the dosage form within the recipient's oral cavity adjacent to recipient's mucosal tissue;
- and
- c) permitting the dosage form to reside adjacent the mucosal tissue for a period of time sufficient to deliver nicotine across the mucosal tissue.
Dependencies are inferred from the claim text.