ABSTRACT
The effectiveness of pharmaceutical drugs depends not only on their active components and manufacturing processes, but also on the role played by pharmaceutical excipients. The traditional definition of excipients as inactive and cost-effective substances has evolved significantly. They are now recognized as essential elements of drug formulations, constituting 80-90% of the final product. The rapid advancements in delivery systems, along with scientific, regulatory, financial and technological developments in biopharmaceutics, have generated renewed interest in the use and functionality of excipients, especially in solid dosage forms. This review focuses on the categorization of excipients according to the International Pharmaceutical Excipient Council (IPEC) and the establishment of guidelines for evaluating the safety of a new proposed excipient.
Excipients are matter we add to medicine when we make it. They give the medicine different qualities, like making it easier to dissolve, stick together, or slide smoothly. But if we use too many excipients, it can make the medicine less stable and more expensive. To avoid these problems, we can use special excipients that can do more than one thing. These multi-purpose excipients make the medicine work better, stay stable and cost less.
Subject(s)
Chemistry, Pharmaceutical , Excipients , Drug Compounding , Biopharmaceutics , Pharmaceutical PreparationsABSTRACT
Soy isoflavone (SIF), a natural phytoestrogen, is used in the condition of hormonal imbalance. These isoflavones generally have low solubility resulting in low bioavailability and bioactivity. It is reported that trans-glycosylation by cyclodextrin glycosyltransferase (CGTase) is widely utilized for increasing the solubility and bioavailability of isoflavones. Present investigation was aimed to study the effect of Bacillus coagulans (a probiotic) in potentiating the bioactivity of soy isoflavones in letrozole-induced PCOS. Initial consideration was focused on proving CGTase assay of B. coagulans. After that, animal study was performed to check the enhancement of bioactivity of SIF along with B. coagulans. A total of 36 rats, separated into six groups (6 rats in each), were used. Group I received vehicles, group II received letrozole (1 mg/kg) for 21 days, and group III animals were administered with soy isoflavones (SIF-100 mg/kg). In the case of group IV, V, and VI, animals received SIF (100 mg/kg) along with B. coagulans 0.65, 3.25, and 6.50 mg/kg, respectively. Treatment was given for 2 weeks after induction of disease. All the animals were sacrificed at the end of the study and endpoint parameters were performed. Present investigation revealed that combination of SIF with B. coagulans showed hormone restoration, reduce oxidative stress, recovery in the menstrual cycle, and improvement in ovarian physiology. SIF (genistein & daidzein) together with B. coagulans exhibits a beneficial role in the enhancement of the bioactivity of soy isoflavones. Further, it showed that a higher dose of B. coagulans (6.50 mg/kg) is more effective in ameliorating the PCOS symptoms.
