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Solid pharmaceutical preparation

A solid pharmaceutical preparation and preparation technology, which can be used in drug combination, drug delivery, antipyretic and other directions, and can solve problems such as low pH value dependence

Active Publication Date: 2009-04-15
NIPPON ZOKI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, Patent Document 1 does not describe any long-acting preparations having excellent release characteristics with little pH dependence in the initial dissolution of opioids, and techniques for completing such preparations.

Method used

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  • Solid pharmaceutical preparation
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] 2450 g of tramadol hydrochloride, 630 g of lactose, 273 g of crystalline cellulose, and 1470 g of partially gelatinized starch were mixed and pulverized, and granulated with a liquid in which 49 g of hydroxypropyl cellulose was dissolved in purified water. 28 g of magnesium stearate was added to the granulated granules and mixed to prepare immediate-release granules. On the other hand, 1625 g of tramadol hydrochloride, 3000 g of hydroxypropyl cellulose, and 150 g of carboxymethylcellulose sodium were mixed and pulverized, and granulated with purified water. 675 g of carboxyvinyl polymer was added to the granulated granules and mixed, and then 50 g of magnesium stearate was added and mixed to prepare sustained-release granules. The immediate-release granules and the sustained-release granules thus obtained were compressed into tablets to obtain tramadol bilayer tablets containing 100 mg of tramadol hydrochloride per tablet. In addition, for the formulations of 75 mg and...

Embodiment 2

[0072] [Example 2] Research on excipients

[0073] Immediate-release portions for 100 mg tablets of formulation A using lactose and crystalline cellulose as excipients and formulation B using only crystalline cellulose as excipients were prepared. The compounding quantity of each containing component per 1 tablet is shown in Table 4. Tablets having a tramadol hydrochloride content of 100 mg / tablet having the composition shown in Table 4 were produced according to the following preparation method.

[0074] [Table 4]

[0075]

[0076] 350g of tramadol hydrochloride, 133g of excipients (prescription A: 93g of lactose and 40g of crystalline cellulose, prescription B: 133g of crystalline cellulose), 210g of partially α-gelatinized starch were mixed, pulverized, and granulated with purified water . 7 g of magnesium stearate was added to the granulated granules and mixed to prepare immediate-release granules.

[0077] In the same manner as in Test Example (1), immediate-releas...

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Abstract

It is intended to provide a long-acting solid pharmaceutical preparation which has an immediate release part and a sustained release part containing tramadol or a pharmaceutically acceptable salt thereof, is fast-acting and stably has an excellent release property showing little pH dependency in the initial elution. The invention relates to a long-acting solid pharmaceutical preparation characterized by having an immediate release part and a sustained release part, containing tramadol or a pharmaceutically acceptable salt thereof as an active ingredient in both parts and containing partially pregelatinized starch and an excipient as additives in the immediate release part. The preparation of the invention is a long-acting preparation in which an effective blood concentration is reached rapidly after taking it for rapid pain-relief and a drug action can be sustained for a long time thereafter and is practical as a preparation showing a stable, pH-independent and rapid initial elution behavior and, further, having a sufficient hardness enough to meet the need for avoidance of detrition, cracking, chipping, etc. during tablet coating.

Description

technical field [0001] The present invention relates to a solid pharmaceutical preparation containing tramadol as an active ingredient and having an immediate-release part and a sustained-release part. Background technique [0002] Now, with the advancement of pharmaceutical technology, in order to improve patient compliance, the development of sustained-release preparation technology for various drugs is being carried out. Compared with the usual immediate-release preparations, the sustained-release preparations can effectively elicit the potential efficacy of the drug while reducing the number of administrations, and can reduce the expression of side effects or toxicity, etc., by making the drug effect last. Sexual advantages are many. [0003] However, in analgesics and the like that also require quick-acting properties, quick-acting properties such as analgesic effects and the like are also desired to be achieved quickly after administration. As a formulation that has ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/135A61K9/22A61K9/28A61K47/26A61K47/36A61K47/38
CPCA61K31/135A61K9/28A61P25/04A61P29/00A61K9/209A61K47/38A61K47/26
Inventor 石坪直树
Owner NIPPON ZOKI PHARM CO LTD
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