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Oral transmucosal nicotine dosage form

A technology of nicotine and dosage forms, which is applied in the fields of pill delivery, nervous system diseases, and oral medicine feeding equipment, etc. It can solve the problems of delay in the systemic acceptance of active ingredients and the "thinning" of active ingredients, and achieve the effect of convenient tablet size

Inactive Publication Date: 2009-10-21
CEPHALON INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, one problem is that the administration mechanism or dose is heavily mixed with the recipient's saliva and the active ingredient becomes "diluted" in the recipient's mouth
Additionally, the systemic acceptance of the active ingredient can be significantly delayed

Method used

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  • Oral transmucosal nicotine dosage form
  • Oral transmucosal nicotine dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Example 1: Preparation of a packaged oromucosal dosage form (tablet) comprising 2 mg nicotine from nicotine polacrol

[0062] A 200 mg solid oromucosal tablet was prepared with a nicotine poracphos potency (15%) effective to deliver a 2 mg dose of active nicotine. Nicotine pollac, mannitol (spray-dried grade), sodium bicarbonate, citric acid, sodium carbonate, and sodium starch glycolate were sieved and blended in a mixer for a predetermined period of time (approximately 30 minutes). After preparing the mixture, magnesium stearate was then added to the mixture and blended for about 5 minutes. The resulting mixture is then discharged and compressed on a rotary tablet press to form tablets to a defined and predetermined weight (200 mg) and hardness (10N). The tablets are then sorted and packed in aluminum-blister packs. Blending, tableting, and blister packaging operations were all performed under humidity-controlled environmental conditions (less than 25 grains of mois...

Embodiment 2

[0067] Example 2: Preparation of a packaged oromucosal dosage form (tablet) comprising 2 mg of nicotine derived from nicotine bitartrate

[0068] Using a procedure similar to that described in Example 1 above, a 200 mg solid oromucosal tablet containing nicotine bitartrate as the active nicotine source was prepared. The composition of the preparation is shown in the table below:

[0069] Table 2: 2 mg Nicotine (from Nicotine Bitartrate) Tablets

[0070] Element:

[0071] * Nicotine bitartrate dihydrate based on 34% potency and 2 mg dose of nicotine.

Embodiment 3

[0072] Example 3: 2 mg nicotine (from nicotine pollac) formulation for comparison

[0073] Using a procedure similar to that described above in Example 1, a 200 mg nicotine tablet formulation was prepared comprising the remaining excipient components preferred for use in the present invention but excluding the effervescent couple and pH adjusting substances of the present invention . The bulking ingredient mannitol was used in place of the effervescent couple and pH adjusting ingredient amounts in the Nicotine Pollack formulation of Example 1. The resulting formulations are shown in the table below:

[0074] Table 3: 2 mg nicotine (from nicotine pollac) formulations for comparison

[0075] Element:

[0076] * Nicotine Pollack Phosphorus is based on 15% potency and nicotine at a dose of 2 mg.

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Abstract

The invention described herein relates to an oral transmucosal solid dosage form useful in treating nicotine addiction or as a nicotine substitute or replacement. By virtue of the formulation in combination with nicotine, the invention 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.

Description

[0001] relevant application data [0002] This application claims priority to US Provisional Applications 60 / 872,177 and 60 / 872,125, filed December 1, 2006. technical field [0003] The present invention relates to the field of pharmaceutical dosage forms and methods of treatment. In particular, the invention relates to oromucosal dosage forms comprising nicotine or nicotine derivatives, and methods of using the same for the treatment of nicotine withdrawal. Background technique [0004] Many nicotine withdrawal products and therapies are known. These products include lozenges, gums, transdermal patches, and the like. Lozenges and gels provide oral delivery of nicotine, while transdermal patch treatments deliver nicotine through the wearer's skin. These systems are based on the premise that a successful smoking cessation process requires control of the cravings associated with nicotine addiction. A commercially available example of a product in the form of oral lozenges ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/46A61K31/465A61P25/34A61K9/00
CPCA61K9/2054A61J7/003A61K31/465A61K9/2018A61K9/2027A61P25/30A61P25/34
Inventor 维卡斯·阿加瓦尔布赖恩·黑格拉金德拉·K·坎卡里
Owner CEPHALON INC
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