Standardisation of Oral Liquid Ibuprofen suspension for improved stability and efficacy

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Ibuprofen is a non-steroidal anti-inflammatory drug on the World Health Organization’s (WHO) Model list of Essential Medicines. Due to its peripheral anti-inflammatory action, ibuprofen is a useful drug in painful conditions associated with inflammation such as teething pain. This makes ibuprofen suspension one of the main analgesic, antipyretic and non-steroidal anti-inflammatory drugs available for paediatric care on the local market. Ernest Chemists Limited (ECL) a local pharmaceutical manufacturing company in Ghana ventured into the production of ibuprofen suspension. However the product was found to be unstable after 12months under real time stability studies. The focus of this work was to find the cause(s) of the instability of the ECL ibuprofen suspension and to optimise and reformulate a standardised and stable oral ibuprofen suspension. The procedures and properties of the ECL ibuprofen suspension were reviewed by examining the suspension from the raw material stage through processing, packaging, finished product specifications and storage conditions. The effect of environmental conditions such as storage temperature and light on the suspension was also investigated. Furthermore, the effects of product specific factors, like suspension pH on the stability of the product were also investigated. It was deduced from the results of the investigations that the absence of a buffering agent and an antioxidant may have accounted for the instability of the suspension. It was proposed to include a buffering agent and antioxidant in the recommended recipe. Citric acid-sodium citrate system was selected as the buffering agent, while ascorbic acid was chosen as the antioxidant. The one variable at a time (OVAT) principle was used to optimise the new formulation. The optimisation process led to the development of nine different formulations. One of the formulations was assessed as the best and selected as the preferred standard formulation for the ibuprofen suspension which was subjected to accelerated stability studies. The standardised formulation passed the accelerated stability studies pointing to a potentially stable product.
A thesis submitted in fulfillment of the requirements for the award of Master of Philosophy (Pharmaceutics) to the Department of Pharmaceutics Faculty of Pharmacy and Pharmaceutical Sciences College of Health Sciences Kwame Nkrumah University of Science and Technology Kumasi, 2016.