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Formulation and Evaluation of Mucoadhesive Microspheres of Pioglitazone Hydrochloride Prepared by Ionotropic External Gelation Technique

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Journal of Encapsulation and Adsorption Sciences 2016年第1期6卷 22-34页

作者： Nagarajan Sriram prakash katakam Department of Biotechnology Acharya Nagarjuna University Guntur India Department of Pharmaceutics Priyadarshini Institute of Pharmaceutical Education and Research Guntur India

Microspheres containing Pioglitazone hydrochloride were prepared by the ionotropic external gelation method, using sodium alginate with four mucoadhesive polymers namely sodium carboxy methyl cellulose, hydroxy propyl methyl cellulose, carbopol 934 P and cellulose acetate phthalate as coat materials. Ionotropic gelation is a method to prepare microspheres using combination of Ca2+ as cationic components and alginate as anion. The practical yield of prepared microspheres using the ionotropic gelation technique was between 172 mg and 604 mg. The result of the Chi-squared test carried out between the actual (practical) and expected (theoretical) yields showed no significant difference (P < 0.05) which indicated that the ionotropic gelation technique could be successfully employed to prepare pioglitazone microspheres using sodium alginate, sodium carboxy methyl cellulose, carbopol 934 P, HPMC, cellulose acetate butyrate polymers. The drug entrapment efficiency of prepared microspheres showed between 56.12% ± 3.86% to 84.68% ± 2.93% which was significantly higher for ionotropic gelation technique. The highest drug entrapment was found in formulation PMI 8. Swelling index is the capability of a polymer to swell before the drug is released which influences the rate and mechanism of drug release from the polymer matrix. The swelling index of prepared microspheres was in the range of 68% ± 4.52% to 87% ± 0.98%. Pioglitazone HCl microspheres showed controlled release of drug without initial peak level achieving. This type of properties in Pioglitazone HCl microspheres used to decrease side effects, reduce dosing frequency and improve patient compliances. From the all batches PMI 8 is considered the best formulation, because among all other formulations, it shows better extent of drug release up to 82.12% (18 h), good entrapment efficiency (84.68%) and the ex-vivo wash-off test shows the best mucoadhesive property. The in vitro drug release studies do up to 18 h. As

关键词： Diabetes Mellitus Mucoadhesive Microspheres Mucoadhesive Polymers Mucoadhesion Sustained Release Ionotropic External Gelation Technique

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In vitro–in vivo studies of the quantitative effect of calcium,multivitamins and milk on single dose ciprofloxacin bioavailability

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Journal of Pharmaceutical Analysis 2015年第6期5卷 389-395页

作者： Baishakhi Dey prakash katakam Fathi H.Assaleh Babu Rao Chandu Shanta Kumari Adiki Analava Mitra School of Medical Science and Technology Faculty of Pharmacy University of Zawia Department of Pharmaceutical Analysis Nirmala College of Pharmacy

Ciprofioxacin, commonly used in India as an anti-microbial for prolonged use in chronic and non-specific indications, may affect the bioavailability of the drug. The drug prescribed is commonly taken with multivitamins, calcium and milk. A simple and reliable analytical methodology obtaining a correlation with in vivo urinary excretion studies using UV and HPLC and in vitro dissolution studies （IVIVC） has shown a significant increase in elimination rate of ciprofloxacin co-administered with multivitamins, calcium and milk. Appreciable IVlVC results proved that dissolution studies could serve as an alternative to in vivo bioavailability and also support bio-waivers.

关键词： CiprofloxacinAnalytical methodologyBioavailabilityBio-waiverDissolution study

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Simultaneous determination of ezetimibe and simvastatin in rat plasma by stable-isotope dilution LC-ESI-MS/MS and its application to a pharmacokinetic study

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Journal of Pharmaceutical Analysis 2014年第4期4卷 286-294页

作者： Sireesha R.Karanam prakash katakam Babu R.Chandu Nagiat T.Hwisa Shanta K.Adiki Vimta Life Sciences Alexandria Knowledge ParkGenome ValleyHyderabadAPIndia Faculty of Pharmacy University of ZawiaAl-ZawiyaLibya Nirmala College of Pharmacy GunturIndia

A simple, sensitive and specific liquid chromatography-tandem mass spectrometry method was developed for simultaneous quantification of ezetimibe and simvastatin in rat plasma. The deuterium isotopes： ezetimibe d4 and simvastatin d6 were used as internal standards for ezetimibe and simvastatin, respectively. MS/MS detection involved a switch of electron spray ionization mode from negative to positive at retention time 3.01 rain. Samples were extracted from plasma by liquid-liquid extraction using tertiary butyl methyl ether. Chromatographic separation was achieved with Agilent Eclipse XBD-CIs column using mobile phase that consisted of a mixture of ammonium acetate （pH4.5; 10 mM）-acetonitrile （25：75 v/v）. The method was linear and validated over the concentration range of 0.2--40.0 ng/rnL for simvastatin and 0.05-15.0 ng/mL for ezetimibe. The transitions selected were m/z 408.3→271.1 and m/z 412.0→275.10 for ezetimibe and ezetimibe d4, and m/z 419.30 → 285.20 and rrdz 425.40 →199.20 for simvastatin and simvastatin d6. Intra- and inter-batch precisions for ezetimibe were 1.6-14.8% and 2.1-13.4%; and for simvastatin 0.94-9.56% and 0.79-12%, respectively. The proposed method was sensitive, selective, precise and accurate for the quantification of ezetimibe and simvastatin simultaneously in rat plasma. The method was successfully applied to a pharmacokinetic study by oral co-administration of ezetimibe and simvastatin in SD rats.

关键词： Ezetimibe Simvastatin PharmacokineticsRat plasma LC-ESI-MS/MS

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Exploration of natural enzyme inhibitors with hypoglycemic potentials amongst Eucalyptus Spp. by in vitro assays

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World Journal of Diabetes 2014年第2期5卷 209-218页

作者： Baishakhi Dey Analava Mitra prakash katakam Rajeev K Singla School of Medical Science and Technology Faculty of Pharmacy University of Zawiya Division of Biotechnology Netaji Subhas Institute of Technology

AIM: To investigate the presence and potency of natural enzyme inhibitors with hypoglycemic potentials amongst Eucalyptus Spp. by in vitro ***: The leaf extracts of the three different Eucalyptus species [E. globulus(EG), E. citriodora(EC), E. camaldulensis(ECA)] were subjected to in vitro assay procedures to explore the prevalence of natural enzyme inhibitors(NEIs) after preliminary qualitative and quantitative phytochemical evaluations, to study their inhibitory actions against the enzymes like α-amylase, α-glucosidase, aldose reductase, angiotensin converting enzyme and dipeptidyl peptidase 4 playing pathogenic roles in type 2 diabetes. The antioxidant potential and total antioxidant capacity of the species were also ***: Major bioactive compounds like polyphenols(341.75 ± 3.63 to 496.85 ± 3.98) and flavonoids(4.89 ± 0.01 to 7.15 ± 0.02) were found in appreciable quantity in three species. Based on the IC50 values of the extracts under investigation, in all assays the effectivity was in the order of EG > ECA > EC. The results of the ferric reducing antioxidant power assay showed that the reducing ability of the species was also in the order of EG > ECA > EC. A strong correlation(R2 = 0.81-0.99) was found between the phenolic contents and the inhibitory potentials of the extracts against the targeted ***: These results show immense hypoglycemic potentiality of the Eucalyptus Spp. and a remarkable source of NEIs for a future phytotherapeutic approach in Type 2 diabetes.

关键词： Natural enzyme inhibitors Hypoglycemic Eucalyptus In vitro assays Pathogenic Polyphenols Flavonoids

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Computational pharmacokinetics and in vitro-in vivo correlation of anti-diabetic synergistic phyto-composite blend

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World Journal of Diabetes 2015年第11期6卷 1179-1185页

作者： Baishakhi De Koushik Bhandari Nishant Chakravorty Ranjan Mukherjee Rohit Gundamaraju Rajeev K Singla prakash katakam Shanta K Adiki Biswajoy Ghosh Analava Mitra School of Medical Science and Technology IIT Kharagpur 721302 India Department of Medical Microbiology Faculty of Medicine University of Malaya Division of Biotechnology Netaji Subhas Institute of Technology Faculty of Pharmacy University of Zawiya Nirmala College of Pharmacy

Despite tremendous strides in modern medicine stringent control over insulin resistance or restoration of normoglycemia has not yet been *** the growth of molecular biology,omics technologies,docking studies,and in silico pharmacology,modulators of enzymes and receptors affecting the molecular pathogenesis of the disease are being considered as the latest targets for anti-diabetic *** molecular targets are now being developed basing on the up or down regulation of different signaling pathways affecting the *** antidiabetic therapy is in vogue both with classical and non-classical medicinal *** its chemoprofiling,structural and pharmacokinetic validation awaits providing recognition to such formulations for international *** health research with its focus on benchside product development and its sequential transition to patient bedside puts the pharma RDs to a challenge to develop bio-waiver *** simulation models and establishment of in vitro-in vivo correlation can help to replace in vivo bioavailability studies and provide means of quality control for scale up and post approval *** attempts to bring different shades highlighting phyto-synergy,molecular targeting of antidiabetic agents via different signaling pathways and bio-waiver studies under a single umbrella.

关键词： In silico pharmacology Phytosynergistic Anti-diabe

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