Abstract
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 nonwater 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.Keywords: Dry powder for suspension; Moisture content; Colour; Stability; Moisture migration; Interaction
Highlights
Many solid pharmaceutical products may sorb moisture during long-term storage as commonly used packaging materials are permeable to moisture content
The moisture content of packaged products can be used as critical criterion for judging the quality of products that are degraded by moisture
Colour change of the mixture was slight when kept in hermetically sealed bottles; on the other hand, those in unsealed bottles showed pronounced colour change and segregated lumps were noticeably formed as well as sticking of the powder to the interior surface of the bottle, especially those stored at the higher temperature of 40 oC
Summary
Many solid pharmaceutical products may sorb moisture during long-term storage as commonly used packaging materials are permeable to moisture content. This study was carried out to investigate the effect of moisture sorption at two different storage conditions on dry powder for oral suspension and predict the effect of moisture interaction on the reconstituted formulations in order to reduce the cost and cycle time of product development. Determination of moisture uptake of the formulations in the amber-coloured glass bottles was carried out at two different conditions. One bottle was withdrawn from the humidity chamber (for each storage condition) over a period of 12 weeks and moisture content (%), colour change and excipient interaction were assessed. The sodium chloride crystals were first powdered in a mortar with a pestle, passed through 600 micron and dried at 105 °C for 1 h, in a wide mouth stainless steel container on a temperature controlled hot place to remove any adsorbed moisture and placed over calcium chloride desiccator before adding to the bottle. Data were analysed using Student’s t-test and one way analysis of variance (ANOVA), and differences were considered statistically significant at P < 0.05
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