Fenina

Citrullus colocynthis Schrad., traditional Tunisian medicinal plant, showed beneficial effects against oxidative stress mediated diseases, namely its fruits and seeds which contain several compounds with biological activity. The present study reports the antioxidant and the antiproliferative properties of different seed and fruit organic extracts. Antioxidant activity was assessed by the ability to quench the free DPPH and the superoxide anion radicals and inhibit the ABTS cation. Methanol extracts presented the highest DPPH scavenging (seeds IC50 = 0.178 mg/ml; fruit IC50 = 0.223 mg/ml) and superoxide scavenging (seeds IC50 = 28.102 µg/ml; fruits IC50 = 30.793 µg/ml) activities. All extracts inhibited the ABTS radical formation. The most interesting TEAC values were registered with methanol extracts (seeds = 1.225 and fruits = 1.120). Petroleum ether seed extract showed the lower antioxidant action. Seed and fruit organic extracts were also tested for their antiproliferative activity on HT-29 human cell line. All extracts induced a concentration dependent growth inhibition. Petroleum ether seed extract exhibited the higher growth inhibition activity (IC50 = 321 µg/ml), while methanol fruit extract showed the less antiproliferative efficiency (IC50 >500 µg/ml). Data obtained indicate that seeds and fruits constitute an excellent source of effective natural antioxidants and chemopreventive agents.

Generic forms of chemically- synthesized drugs must exhibit chemical identity and be bioequivalent in healthy human subjects. Biologic products are 100- to 1,000-fold larger than chemically synthesized drugs, with sophisticated three-dimensional structures, and can be mixtures of isoforms rather than pure homogeneous entities. Therefore, the development process for biosimilars is more complex than for a true generic and the demonstration of approvability for biosimilars differs from the standard generics approach as it is based on a comparability exercise rather than on demonstration of bioequivalence. This study examines the case of a Low-molecular-weight heparins (LMWHs): enoxaparin which is among smallest biological molecules. Different chemical tests such as Nuclear Magnetic Resonance (NMR), Size exclusion Chromatography, Specific absorbance, stability tests and biological assay (anti-factor Xa activity and anti-factor II a activity) were used for a comparability exercise focusing on quality and structural aspects of enoxaparin biosimilar product compared to the reference product. All tests and comparative studies showed no significant difference. in fact the data observed suggests comparable results even under accelerated conditions of stability study. This study suggests that there is no significant difference in the profile structure and overall studied quality aspects of the reference product compared to the similar biological medicinal product. however specific analytical methods as well as additional biological and pharmacological tests may be used to address their interchangeability.