EXPERIMENTAL EVALUATION OF PRACTICAL VIABILITY OF GOOD MANUFACTURING PRACTICE (GMP) IN PREPARATION OF ORAL LIQUID FORMULATIONS IN SMALL SCALE PHARMACEUTICAL INDUSTRIES

Susmita Pal, Souvik Basak, Suman Roy, Debalina Sinha Roy, Shauroseni Palchoudhuri,
*Sujata G. Dastidar

ABSTRACT

Oral liquid formulations have a much greater possibility of getting contaminated by airborne bacteria than other pharmaceuticals. Such bottles should be closed immediately after opening to avoid the chances of contamination. However, due to their alkalinity antacids are highly prone to contamination. According to international regulation, bacterial count in liquids should not exceed 100 bacteria per ml and also that packaging area should have air handling unit (AHU). To determine practical importance of AHU, standard antacids were prepared in AHU, inside laminar air flow (LAF) system and in the general microbiology laboratory (ML) fitted with air conditioners. Samples were kept in coloured polyethylene terepthalate bottles and bacterial count was evaluated following standard procedures. Bacterial counts were determined simultaneously from two common antacids available in the market. Although number of bacteria varied from 2.33 to 4.66 in 10-1 dilution, the number was 0.33 in 10-2 dilution of antacids prepared in AHU and LAF and the number was 1 in the ML, proving thereby the expertise of the technical persons responsible for preparing the antacids. Isolated bacteria were identified as Staphylococcus spp. in all preparations, while Bacillus spp. could be detected in the antacids prepared in LAF and ML. An almost identical finding was observed in antacids purchased from the market. Thus this study very clearly proves that the use of AHU may not be made an absolute mandatory for small industries. They may be allowed and advised to manufacture their oral liquid formulations in properly maintained LAF by expert pharmacists.

Keywords: Antacid suspension, liquid formulation, Air handling unit, Laminar air flow, Bacterial count.