STANDARDISATION OF ORAL LIQUID IBUPROFEN SUSPENSION FOR IMPROVED STABILITY AND EFFICACY

ABSTRACT
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.


CHAPTER ONE
GENERAL INTRODUCTION AND LITERATURE REVIEW
1.1 Background
Pharmaceutical formulation is the process of combining active pharmaceutical ingredients (API) and other chemical substances (excipients) to produce a medicinal product (Hassan, 2012). In order to enhance product delivery to the patient, pharmaceutical products are formulated into specific dosage forms. Each dosage form requires specific pharmaceutical technology and the accompanying technical challenges for formulation development. Oral liquid formulations are usually solutions, emulsions or suspensions containing one or more active pharmaceutical ingredients in a suitable vehicle; the active pharmaceutical ingredient may be a solid or a liquid which might be used as such (International Pharmacopoeia, 2008). One of the major challenges with oral liquid products is poor aqueous solubility which impacts on bioavailability of the active ingredient (Kesisoglou et al., 2007). The poor aqueous solubility may lead to the formulation of an oral liquid preparation as a suspension. The other reasons for suspension formulation include masking the bitter taste of the active ingredient, improving the stability of the active ingredient and to achieve controlled release of the product (Kulshreshtha et al., 2010).

Pharmaceutical formulations must be stable in order to ensure safety, quality and efficacy. The stability of a pharmaceutical dosage form is defined as the ability of the product in a specific container or container closure system to maintain its physical, chemical, microbial and safety specifications (Kommanaboyina and Rhodes, 1999). Physical, chemical and microbiological stability can be achieved by the addition of appropriate excipients such as buffering agents, antioxidants and preservatives (Nunn and Williams, 2005).

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Item Type: Ghanaian Postgraduate Material  |  Attribute: 114 pages  |  Chapters: 1-5
Format: MS Word  |  Price: GH50  |  Delivery: Within 30Mins.
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