| Abstract: |
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age, and one of the most common causes of female ovulatory infertility. Usually, the condition can be managed with the oral ovulation- inducing agent clomiphene citrate (CC), but only 75% of patients respond positively. Women who do not respond are termed clomiphene resistant, and their treatment options are either by gonadotrophins which are associated with life-threatening complicatio laparoscopic ovarian drilling. Since the choice of therapy often comes down to issues of efficacy, cost, ease of use and side effects, many researchers have studies other less strenuous treatment options for treatment of clomiphene resistant PCOS. One of the novel treatment options is using N-acetylcysteine (NAC) as an adjunct to CC.In the light of the above mentioned criteria, the study in this thesis is concerned mainly with the possibility of formulation of a novel fixed dose combination tablet containing either 300 mg NAC with 25mg CC or 200 mg NAC with 16.66 mg CC. Being the drug with the highest dose, NAC was primarily formulated into tablets using different conventional fillers and binders. The tablets were prepared by direct compression technique (DCT) orwet granulation technique (WGT). Then the combination tablets were formulated by replacing a portion of the filler by CC. Furthermore, the best formula for the combination tablet was chosen for clinical assessment.Pharmaceutical evaluation of the different formulations included evaluation of the flow characteristics of the powder for DCT or granules for WGT and evaluation of the prepared tablets. The flowability was determined by angle of repose and Carr’s index. For tablet evaluation, each of weight variation, hardness, friability, hardness to friability ratio, disintegration time as well as drug release rate from the prepared tablets, was assessed. In addition, kinetic studies were performed from which the order of release kinetic was determined. Also, short-term stability of the prepared tablets with respect to the physical properties and release characteristics, after storage at room temperature, were assessed.On the other hand, clinical evaluation of the chosen tablet formula
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