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Solid pharmaceutical preparation

A technology of solid pharmaceutical preparations and additives, applied in the direction of drug combination, sugar-coated pills, pill delivery, etc., can solve the problem of small pH dependence and achieve high practicability

Inactive Publication Date: 2007-09-05
NIPPON ZOKI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no description in Patent Document 1 about a long-acting opioid formulation having an excellent release characteristic with little pH dependence in the initial dissolution stage and a technique for realizing such a formulation.

Method used

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  • Solid pharmaceutical preparation
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0025] The following examples are given to describe the present invention concretely, but the present invention is not limited to these examples.

[0026] Embodiment and comparative example: preparation method of tablet

[0027] Regarding the preparations of Examples prepared according to the formulation of the solid pharmaceutical preparation of the present invention and the preparations of Comparative Examples prepared according to the formulation of the solid pharmaceutical preparation of the present invention having different additives (refer to Japanese Patent Application No. 2004-288138), in Table 1 shows the compounding quantity of each contained component per 1 tablet. Each tramadol hydrochloride of the embodiment (tramadol hydrochloride content is 100, 75 and 50mg / tablet) and comparative example (tramadol hydrochloride content 100mg / tablet) of the composition shown in table 1 is produced by the following preparation method Multiple layers.

[0028]

Pre...

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Abstract

To provide a sustained-release solid pharmaceutical preparation having a quick-release part and a sustained-release part and stably having an excellent quick releasing characteristic with little pH dependency in an initial dissolution. The present invention relates to that, in a preparation containing a medical ingredient as an effective ingredient, particularly active analgesic ingredient, a sustained-release solid pharmaceutical preparation which is characterized in that it is a solid pharmaceutical form having a quick-release part and a sustained-release part and contains effective ingredient in both parts and the quick-release part contains a partly pregelatinized starch and a low substituted hydroxypropylcellulose as additives. In the preparation of the present invention, stable and quick initial dissolution behavior being independent upon pH is achieved even when some sustained-release part is contaminated in the quick-release part due to the difference in the tabletting method for multi-layered tablets. Furthermore, the preparation is practical as a preparation having a sufficient hardness in view of necessity that abrasion, breakage, crack, etc. are not generated when the tablet is coated.

Description

technical field [0001] The present invention relates to a solid pharmaceutical preparation having an immediate-release part and a sustained-release part. Background technique [0002] Currently, with the advancement of formulation technology, development of sustained-release formulation technology is being carried out for various drugs aimed at improving patient compliance. Compared with the usual immediate-release preparations, the sustained-release preparations can continuously exert the drug effect, so that while effectively exerting the potential effect of the drug, it can reduce the number of administrations, reduce the occurrence of side effects or toxicity, etc., in terms of effectiveness, safety The advantages of sex are many. [0003] However, analgesics and the like that require quick action are also required to have quick action such that they rapidly reach an effective blood level after administration to exert an analgesic effect. As preparations having both th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/36A61K9/24A61K9/28A61K31/137A61K45/00A61K47/02A61K47/38
CPCA61K31/137A61K9/209A61P25/04A61K9/20A61K47/36A61K9/28
Inventor 石坪直树
Owner NIPPON ZOKI PHARM CO LTD
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