B K Nanjwade1 
,
Shamrez M Ali1,
F V Manvi1,
M M Kanakal2
For correspondence:- B Nanjwade Email: bknanjwade@yahoo.co.in Tel:+918312471399
Received: 2 July 2009 Accepted: 7 October 2009 Published: 23 February 2010
Citation: Nanjwade BK, Ali SM, Manvi FV, Kanakal MM. Effect of Tropical Climatic Conditions on the Stability of Cefaclor Dry Powder for Suspensions. Trop J Pharm Res 2010; 9(1):73-79 doi: 10.4314/tjpr.v9i1.10
© 2010 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
Purpose: Two critical factors that govern the stability of pharmaceutical formulations in the tropics are humidity and temperature. This study was carried out to investigate the effect of moisture sorption at two different storage conditions on Cefaclor dry powder for oral suspension and predict the effect of moisture interaction on the reconstituted formulations.
Method: Cefaclor dry powder for suspension formulation was taken as a model formulation for this study. Different formulations were manufactured and placed in twelve amber coloured glass bottles for each test condition. One set of bottles was sealed by heat induction technique under vacuum to ensure the integrity of the seal while the other set was without a seal but had a child-resistant cap. Both types of bottles were stored in humidity chambers at 30°C/65%RH or 40°C/75%RH. Weight changes were monitored on a dynamic moisture balance over a period of 3 months.
Results: The results were recorded in terms of moisture content, colour, and excipient interaction and their effect on product appearance. The data were analyzed using Students t-test and one way analysis of variance (ANOVA), and differences were considered statistically significant at P < 0.05.
Conclusions: The study revealed that the product with enhanced packaging and also contained non-water soluble colourants were more protected against the deleterious effects of moisture and temperature. The findings provide an insight into a possible approach for formulating moisture-sensitive pharmaceutical products, especially dry powder preparations for use in the tropics.
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