Packaging for amorphous statins and compositions thereof

a technology of amorphous statins and packaging, which is applied in the direction of containers, tray containers, diagnostics, etc., can solve the problems of reducing the therapeutic effect of an active substance, and unnecessarily burdening the body with degradation products, etc., to achieve easy detection, improve stability, and reduce the effect of oxidation

Inactive Publication Date: 2009-03-19
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]There is still a need for providing a packaging system for amorphous statin so as to enhance their stability. This can be provided by applying a vacuum, which provides additional benefits. Vacuum packed systems require a minimum of space (as compared to inflated bags produced by introduction of inert gases). Vacuum packaged systems are less prone to leakage and any leakage can be easily detected.

Problems solved by technology

However, amorphous forms can be susceptible to oxidation, heat, light, moisture and low pH, as compared to crystalline forms.
Impurities generated upon degradation of active substances can reduce the therapeutic effects of an active substance and unnecessarily burden the body with degradation products.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0078]Atorvastatin drug substance (amorphous) was packaged for long term use or transporting according to various packaging options as described below:[0079]1. Amorphous atorvastatin was packaged in a LDPE bag and flushed with nitrogen gas; the bag was twisted and tied; the bag was put into a double laminated bag along with oxygen absorber and flushed with nitrogen gas; vacuum was applied to the double laminated bag and heat sealed; the sealed double laminated bag was packaged into a triple laminated bag along with molecular sieve and flushed with nitrogen gas; vacuum was applied to the triple laminated bag and heat sealed.[0080]2. Amorphous atorvastatin was packaged in a LDPE bag and flushed with nitrogen gas; the bag was twisted and tied; the bag was put into a double laminated bag along with oxygen absorber and silica gel; vacuum was applied to the double laminated bag and heat sealed; sealed double laminated bag was packaged into a triple laminated bag along with molecular sieve...

example 2

[0084]Atorvastatin tablets according to WO 03 / 068191 were packaged in following packaging options and were subjected to stability studies:[0085]1. Tablets and molecular sieve were packaged in a double laminated bag and vacuum sealed; double laminated bag was packaged into a HDPE bottle containing oxygen absorber,[0086]2. Tablets and molecular sieve were packaged in a triple laminated bag and vacuum sealed; triple laminated bag was packaged into a HDPE bottle containing oxygen absorber,[0087]3. Tablets and molecular sieve were packaged in a double laminated bag and vacuum sealed; vacuum sealed bag was then put in a triple laminated bag containing oxygen absorber; and packaged into a HDPE bottle.

[0088]Example 2, option 2 and 3 were subjected to stability studies at 40° C. and 75% RH, the results are given in the Table 2:

TABLE 2The stability data of Atorvastatin tablets as per Example 2, option 2 and 3at 40° C. and 75% RH.1 month3 monthImpurity typeInitialOption 2Option 3Option 2Option...

example 3

[0089]An exhibit batch was taken for Atorvastatin tablets according to WO 03 / 068191; and were packaged in following packaging options and subjected to stability studies:[0090]1. A total of 30 tablets were packaged in a triple laminated bag and vacuum sealed; triple laminated bag was packaged into a HDPE bottle containing oxygen absorber and the bottle was sealed using heat induction.[0091]2. A total of 90 tablets were packaged in a triple laminated bag and vacuum sealed; triple laminated bag was packaged into a HDPE bottle containing oxygen absorber and the bottle was sealed using heat induction.[0092]3. A total of 90 tablets were packaged in a triple laminated bag and vacuum sealed; triple laminated bag was packaged into a HDPE bottle containing molecular sieve and the bottle was sealed using heat induction.

[0093]Example 3, option 1-3 were subjected to stability studies at 40° C. and 75% RH after 3 months.

TABLE 3The stability data of Atorvastatin tabletsas per Example 3 at 40° C. a...

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Abstract

The present publication relates to a vacuum-sealed pack comprising an amorphous statin or a pharmaceutical composition thereof and at least one stabilizer such as, for example, an oxygen absorber, a moisture absorber or a combination thereof.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a vacuum sealed pack comprising an amorphous statin and at least one stabilizer such as, for example, an oxygen absorber, a moisture absorber or a combination thereof.BACKGROUND OF THE INVENTION[0002]Statins are currently among the most therapeutically effective drugs available for reducing the level of LDL in the blood stream of a patient at risk for cardiovascular disease. Statins are also known to raise HDL cholesterol levels and decrease total triglyceride levels. The mechanism of action of statins has been elucidated in some detail. It is believed that statins disrupt the biosynthesis of cholesterol and other sterols in the liver by competitively inhibiting the 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase enzyme (“HMG-CoA reductase”). HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonate, which is the rate determining step in the biosynthesis of cholesterol. Consequently, its inhibition leads to a re...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B65D85/00
CPCA61J1/00A61J1/16A61K31/40A61K9/2018A61K9/2054A61K9/2009
Inventor BAHUGUNA, SUMITMUNSHI, ANINDYAMATHUR, RAJEEV SHANKARAGGARWAL, SWATISINGH, ROMI BARATSATHYANARAYANA, SWARGAMKUMAR, SARIDI MADHAVA
Owner RANBAXY LAB LTD
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