Abstract: The quest for the use of plants in the management of reproductive hormone dysfunction prompted this research. This study explored the effects of Ricinodendron heudelotti seed ethanol extract on some male reproductive hormones. Twenty five male albino rats were used. The animals were grouped into five and each group had five (5) albino rats. The extract was processed from the seeds of Ricinodendron heudelotti. Group A served as control, group B animals were administered with 300mg/kg.bw, while groups C, D and E animals were administered 450, 600 and 750 mg/kg.bw of the extract respectively for twenty one days. The animals were sacrificed and their blood samples were collected for the assay of testosterone, Follicle stimulating hormone (FSH) and Luteinizing hormone (LH). From the results obtained, the serum testosterone level of the experimental animals showed a concentration dependent increase in all the extract administered groups when compared with the value of the control group. FSH and LH levels showed an increase statistically (p≤0.05) in comparison to the level of the control. Ricinodendron heudelotti seed extract effectively increased the reproductive hormones of the animals by increasing the serum Testosterone, FSH and LH levels, hence suggests its effectiveness in enhancement of the male reproductive function.Abstract: The quest for the use of plants in the management of reproductive hormone dysfunction prompted this research. This study explored the effects of Ricinodendron heudelotti seed ethanol extract on some male reproductive hormones. Twenty five male albino rats were used. The animals were grouped into five and each group had five (5) albino rats. The ext...Show More
Abstract: In vitro dissolution testing is an important tool used for pharmaceutical development and approval of generic medicinal product, playing a pivotal role in regulatory decision-making. This study includes evaluation and comparative analysis of in vitro dissolution profiles of Bisoprolol film-coated tablets and in vitro dissolution profile of a reference medicinal product, using several model-independent and model-dependent statistical methods. The evaluated medicinal product belongs to BCS Class I (high solubility, high permeability). The similarity testing of dissolution profile is performed on the highest strength of the dosage form, in accordance with the regulatory requirements for bioequivalence study. Obtained results have shown that in vitro comparative dissolution analysis using pair-wise independent-model procedures, such as difference (f1) and similarity (f2) factors are not suitable, because one of the requirements (not more than one mean value dissolves more than 85%, for any of the formulations) was not fulfilled. Therefore, the comparison of the similarity of dissolution profiles was performed using Ratio test methodology and multivariate model-independent approach based on generalized statistical distance (Mahalanobis distance). Furthermore, other model-dependent approaches coupled to multivariate statistics (Weibull) were applied. The obtained results from the performed analysis indicated a significant similarity of the compared in vitro dissolution profiles between the tested batches from bisoprolol film-coated tablets and reference medicinal product). Implemented statistical methods can be considered as a regulatory accepted concept for evaluation of in vitro similarity of generic medicines.Abstract: In vitro dissolution testing is an important tool used for pharmaceutical development and approval of generic medicinal product, playing a pivotal role in regulatory decision-making. This study includes evaluation and comparative analysis of in vitro dissolution profiles of Bisoprolol film-coated tablets and in vitro dissolution profile of a refere...Show More
