Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution.

In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing nations. This up rise in generic drug market is expected to rise in future till the arrival of new brand in market. This prevailing conditions could result in proliferation of generic drug manufacturing companies. The fact that generics do not undergo thorough extensive trials like innovator drugs, fuels further fears regarding their inferiority. Moreover, due to the hard competition amongst various companies to market their generics, the frequency of fraud and corruption have embarked doubts in consumers mind to reality. In order to blow away the doubts and re-establishing the credibility of generics in market, bioequivalence (BE) guidelines with stricter regulation should be the demand. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in US, Europe, Canada, India, South Africa and South East Asian Nations. A comparative study of the differences in study design and specifications have also been addressed.

Synthesis, antimicrobial evaluation and QSAR studies of N'-benzylidene/(1-phenylethylidene)undec-10-enehydrazides.

A series of N'-benzylidene/(1-phenylethylidene)undec-10-enehydrazide was synthesized starting from undec-2-enoic acid through multi-step reactions. Synthesized derivatives were evaluated for their in vitro antimicrobial activities against Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Aspergillus niger and Candida albicans by tube dilution method. The preliminary results showed the significance of o-NO2, m-NO2 and m-OCH3 groups at phenyl ring in describing antimicrobial activity of synthesized compounds. QSAR studies revealed that second order molecular connectivity index (2χ) and Balaban topological index (J) are the key parameters for antimicrobial activity of synthesized hydrazide derivatives and can be cosidered as important factors for interaction with target site of different microorganisms. It is pertinent to note that multi-target QSAR models were more significant in demonstrating the antimicrobial activity than one-target QSAR models.

Antibacterial, antitussive, antioxidant and toxicological evaluation of Joshanda lozenges.

Joshanda, a Greco-urban formulation comprising seven herbs has been used since centuries for the treatment of cold, cough and associated allergic reactions. Conventionally, it is used in the form of an extemporaneously prepared decoction. However, in the current scenario, lozenges happen to be the dosage form of choice for antitussive drugs. In case of polyherbal drugs, the dosage form assumes a great importance in order to ensure that all the phyto-components exert their pharmacological effect to the maximum. Based on the popularity of lozenges, conventional decoction form of Joshanda was formulated in the form of lozenges. Lozenges were evaluated for routine quality control tests. The most remarkable feature of the formulation was that excellent compression, hardness, friability and disintegration properties could be achieved without the addition of any external binder. The prepared formulation was subjected to in vitro antioxidant activity, antibacterial activity against common respiratory tract pathogens, in vivo antitussive activity and acute toxicity studies using Albino Wistar mice. Accelerated stability studies were conducted as per ICH guidelines. The performance of lozenges was found to be satisfactory in all the tested aspects. Our study proposes the use of lozenges as a preferred dosage form of the conventionally used decoction of Joshanda.

Formulation and characterization of ternary complex of poorly soluble duloxetine hydrochloride.

Duloxetine hydrochloride (DXH) suffers from poor solubility and thereby poor absorption, which ultimately leads to poor bioavailability. In present study, an attempt has been made to formulate and characterize duloxetine hydrochloride (DXH) complex, using β-cyclodextrin (β-CD) and different hydrophilic polymers in order to enhance its solubility and dissolution rate. Phase solubility study was used to investigate the interaction of the drug in binary systems (DXH-β-CD) as well as ternary systems (DXH-β-CD-hydrophilic polymer). It was observed that solubilization of DXH by β-CD was further enhanced by using HPMC K4M at 0.1% w/v concentration. Several methods were used to prepare ternary complex of DXH-β-CD-HPMC K4M. Ternary complex prepared by co-evaporation method containing DXH-β-CD-HPMC K4M in the ratio of 1:1.10:0.01 has shown the fastest dissolution rate (53.65 ± 2.83% in 5 min) as compared to pure DXH (3.03 ± 1.88% in 5 min) as well as other methods used to prepare these complexes. The prepared ternary complex system was characterized by the help of X-ray powder diffraction studies, differential scanning calorimetry and scanning electron microscopy. It was observed that enhancement in solubility as well as dissolution rate of DXH was due to formation of ternary complex system.

Synthesis, molecular docking and QSAR studies of 2, 4-disubstituted thiazoles as antimicrobial agents.

In present study a series of 2,4-disubstituted thiazole derivatives was synthesized and evaluated for their in vitro antibacterial and antifungal activities against B. subtilis, E. coli, S. aureus, C. albicans and A. niger by tube dilution method. The analysis of antimicrobial activity results indicated that the presence of NO2 and OCH3 groups at para position of phenyl group improved the antimicrobial activity significantly. Molecular docking studies also supported in vitro activity results and showed that NO2 and OCH3 groups containing compounds have greater affinity towards the target glucosamine-6-phosphate synthase. QSAR studies indicated that molecular connectivity index (2χv) and Kier’s shape index (α3) are the key parameters for antimicrobial activity of synthesized thiazole derivatives and can be cosidered as important factors for interaction with target site of different microorganisms. It is pertinent to note that multi-target QSAR models were more effectual in demonstrating the antimicrobial activity than one-target QSAR models.

Role of C.T. Scanning in Characterization of USG Detected Solid and Cystic Lesion of Liver.

The exact nature i.e. neoplastic vs. benign of USG detected space occupying lesions are confirmed by computed tomography. In this study we do CECT of 45 cases of sonographically detected space occupying lesions in liver. Some of cases which is very confusing in regards either it is benign or malignant, the computed tomography is more sensitive.

Role of Ultrasonography in the Diagnosis of Intrahepatic Space Occupying Lesions.

Ultrasonography is safe, non- invasive, cost-effective, less time-consuming, easily repeatable and simple investigation for the diagnosis and follow up of intrahepatic space occupying lesions. In these study ninety patients with a probable diagnosis of space occupying lesions of liver were studied. The diagnosis of intrahepatic space occupying lesions was confirmed in eighty-two patients. Ultrasonography had sensivity of 91%.

Role of CT in the Evaluation of Adult Brain Tumor.

Imaging plays an important role in the evaluation of patients with brain tumors. CT is an important and commonly used modality. They have a significant impact on patient modalities and care. The technical improvement of CT and the utility of contrast material in the imaging of brain tumors improved significantly the detection and the evaluation of brain neoplasms.Once a brain tumor is clinically suspected, radiologic evaluation is required to determine the location, the extent of the tumor and its relationship to the surrounding structures. This information is very important & critical in deciding among different forms of therapy such as surgery, radiation and chemotherapy. In this article we will give an overview of the role of CT in the diagnosis of brain tumors.

Study of Systolic/Diastolic Ratios of the Umbilical Artery Flow Velocity Waveforms in Pregnant Women.

Analysis of umbilical artery flow velocity waveforms of systolic/diastolic (S/D) ratio of 58 patients, who had accurately uncomplicated pregnancies with a normal spontaneous vaginal delivery, were studied. This study includes conventional ultrasonography, color flow mapping and duplex Doppler flow. There was a significant decrease in the S/D ratio over each week of the third trimester of pregnancy. The study present the mean, range and upper limit of the data obtained in this population.