Bioavailability

Cefixime has bioavailability of 40-50%, which could be attributed to its low solubility in GI tract. The objective of this pilot study was to compare the efficacy and safety of improved formulation of cefixime 200 mg tablet (CEFOLAC) versus conventional marketed cefixime 200 mg tablet in patients with typhoid fever (TF). Patients with clinical diagnosis of TF were randomized to receive either treatment twice daily for 10 days. Primary efficacy end point was reduction of clinical symptoms score on day 5 and number of patients with absence of clinical symptoms. Secondary endpoints include microbiological cure and clinical relapse on day 10 and 21. Total 22 patients completed study successfully and were subjected to analysis. Percentage improvement in total clinical symptoms score from baseline to day 5 was greater in improved formulation of cefixime (70 %) than conventional cefixime 200 mg tablet (58 %). On day 5, numbers of patients with complete cure of clinical symptoms were greater in group A as compared to group B. All patients in both the groups were cured based on clinical symptoms and microbiological evaluation on day 10 and day 21. No case of clinical relapse was observed. Both the formulations of cefixime were well tolerated by patients. Improved formulation of cefixime offers faster and greater improvement in clinical symptoms than conventional cefixime tablet in patients with TF. Improved formulation of cefixime is a better option for the treatment of patients with TF than conventional cefixime tablet.

The present study was aimed to study the requirements of bioequivalence for registration of pharmaceutical products in various countries. It is essential for pharmaceutical industry to study the guidelines of bioequivalence for respective country where industry would like to apply for ANDA and thus want to enter into generic market. This study gives insight about requirements of bioequivalence with study parameters such as study design, fasting or fed state studies, volunteers recruitment, study dose, sampling points, analytical method validation parameters, moieties to be measured in plasma, pharmacokinetic parameters, criteria for bioequivalence, GCP requirements etc. which are needed for pharmaceutical industry to carry out bioequivalence studies and to file ANDA. Test products for these bioequivalence studies are usually manufactured by a sponsor or manufacturer while reference is provided by the government laboratories of respective countries. Sampling points also varies with respect to the regulatory guidelines of these countries. India follows Indian GCP guidelines, South-Africa MCC GCP guidelines and Australia follows ICH GCP guidelines. Criteria of bioequivalence, for India and South-Africa is 90% CI 80-125% for Cmax, AUCt, AUCo-inf. for Australia 90% CI 80-125% for Cmax, hAUCt, AUCo-inf.

  Mucoadhesive delivery systems were proven to be suitable for the purpose of reduction of transit time of the dosage form through the gastro-intestinal tract, and increasing bioavailability of drug. Buccal tablets of Carvedilol were prepared by direct compression method for using various compositions of combination of Starch: C934 and Starch: HPMCK15M in various ratios. The tablets were evaluated for their characteristics properties, mucoadhesion and in vitro-in-vivo study. All the physicochemical properties were acceptable within the limit. Formulation containing starch and Carbopol 934(E4) showed better bioavailability as compared to tablet containing  Starch and HPMCK15 (F5) and The bioadhesive strength of the formulations containing polymers were in the order of E4> F5. Stability studies were carried out as per ICH guidelines and formulations were found to be Stable.  

  In ancient Greek ‘Nano’ means dwar. Nanotechnology is the creation and utilization of materials, devices, and systems through the control of matter on the nanometer-length scale, i.e. at the level of atoms, molecules, and supramolecular structures. These technologies have been applied to improve drug delivery and to overcome some of the problems of drug delivery for cancer treatment. The magic of nanoparticles mesmerize everyone because of their multifunctional character and they have given us hope for the recovery from this disease. Nanoparticles can be used to deliver hydrophilic drugs, hydrophobic drugs, proteins, vaccines, biological macromolecules, etc. They can be formulated by aptamer conjugation for targeted delivery to the lymphatic system, brain, arterial walls, lungs, liver, spleen, or made for long-term systemic circulation. Therefore, numerous protocols exist for synthesizing nanoparticles based on the type of drug used and the desired delivery route. In modern medicine technologies the oral administration of solid forms is the preferred route for drug delivery. Thus, in pharmaceutical applications, size, shape and morphology of the solid particles are important because they can affect the solubility as well as bioavailability of the drug particles.