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Nicotine tablet

A technology of nicotine tablets and tablets, which is applied in pill delivery, pharmaceutical formulations, nervous system diseases, etc., can solve the problems of unrealized smoking simulation, and achieve the effect of promoting the absorption of nicotine into the blood stream

Active Publication Date: 2020-07-24
FERTIN PHARMA AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, it is an established fact that one-to-one simulation of smoking through means other than cigarettes has not yet been achieved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Preparation of rapidly disintegrating tablets

[0128] In this example, six fast disintegrating tablets (FDT) with 1 mg nicotine were prepared into the formulations listed in Table 1. Rapidly disintegrating tablets were prepared with NBT (nicotine bitartrate dihydrate). Punch used: 7.00mm, round, dimpled, D tooling (D tooling). Tablet weight: 100.0mg.

[0129] Table 1 - Rapidly disintegrating tablet compositions. Amounts are given in mg. FDT = Fast Disintegrating Tablet.

[0130]

[0131] Weigh ingredients from bags or drums into individual weighing containers.

[0132] Sieve all excipients through an 800 micron sieve into stainless steel or plastic bins in the following order:

[0133] Half of the bulking / bulk sweetener

[0134] · API and all other excipients, except magnesium stearate

[0135] The remaining half of the bulking / bulk sweetener

[0136] They were mixed in a Turbula mixer at 25 RPM for 4 to 10 minutes. The lubricant (eg, magnesium stearate) i...

Embodiment 2

[0143] Preparation of rapidly disintegrating tablets using a ready-to-use system

[0144] Another way to prepare rapidly disintegrating tablets is to use a ready-to-use system. Suitable for this purpose may be but not limited to: Pearlitol Flash (Roquette), Pharmaburst 500 (SPI Pharma), Ludiflash (BASF), ProSolv (JRS Pharma), ProSolv EasyTab (JRS Pharma), F-Melt (Fuji Chemical), SmartEx50 or SmartEx100 (Shin Etsu / Harke Pharma). These ready-to-use systems are co-processed into a powder mix incorporating fillers, disintegrants, glidants or the like. This saves handling of several excipients and ensures uniformity between excipients.

[0145] In this example, five nicotine-free fast disintegrating tablets (FDT(g) to FDT(k)) were prepared with the ready-to-use system in the formulations listed in Table 3A. Rapidly disintegrating tablets were prepared without NBT (placebo). The addition of nicotine to rapidly disintegrating tablets is expected to have only a small effect on dis...

Embodiment 3

[0215] body pH

[0216] Rapidly disintegrating tablets are designed to have an in vivo pH higher than the resting saliva pH in the oral cavity. Therefore, pH is measured in vivo as follows:

[0217] At least 6 individuals chew the unbuffered gum matrix for 1 minute, after which the initial pH is measured in a sample of saliva from each individual with a suitable pH electrode system (eg stainless steel electrode PHW77-SS). Only individuals with an initial pH in saliva in the range of 6.7 to 7.3 after chewing the unbuffered gum matrix for one minute were selected. These individuals thus qualify as average individuals.

[0218] One tablet is administered sublingually to at least six subjects. Thereafter, the saliva pH of each of the six individuals was measured at specified time intervals. Therefore, each pH value is the arithmetic mean of six measurements made on saliva samples from six individuals.

[0219] The sample volume for each saliva sample may vary since the volume o...

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Abstract

The invention relates to an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, the tablet being designed to disintegrate within a period of lessthan 60 seconds upon oral administration, the powder formulation comprising an amount of nicotine and a pH regulating agent.

Description

technical field [0001] The present invention relates to the field of rapidly disintegrating tablets. In particular, the present invention relates to formulations and methods for more effective use of nicotine from rapidly disintegrating tablets administered orally by the sublingual or buccal route. Background technique [0002] Nicotine release tablets that are administered to provide nicotine release in the mouth of a user over a period of time are well known. In the prior art, much effort has been made to simulate the nicotine release and mouthfeel of a cigarette when a user smokes it, which means that the release profile of nicotine tablets has been thoroughly studied in the prior art. [0003] However, it is an established fact that one-to-one smoking simulation by means other than cigarettes has not yet been realized. Contents of the invention [0004] The present invention relates to orally disintegrating nicotine tablets comprising a compressed powder formulation ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/20A61K31/465A61P25/34
CPCA61K9/0056A61K9/2009A61P25/34A61K31/465A61K9/006A61K9/2027A61K9/2095
Inventor 布鲁诺·普罗夫斯特高·涅尔森肯特·阿尔宾·涅尔森
Owner FERTIN PHARMA AS
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