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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