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   2010| April-June  | Volume 2 | Issue 2  
    Online since May 12, 2010

 
 
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PHARMACEUTICS
Formulation and evaluation of extended-release solid dispersion of metformin hydrochloride
SA Patil, BS Kuchekar, AR Chabukswar, SC Jagdale
April-June 2010, 2(2):121-129
DOI:10.4103/0975-1483.63147  PMID:21264113
The purpose of this research was to formulate and characterize solid dispersion (SD) of metformin hydrochloride using methocel K100M as the carrier by the solvent evaporation and cogrinding method. The influence of drug polymer ratio on drug release was studied by dissolution tests. Characterization was performed by fourier transform spectroscopy (FTIR), ultraviolet, differential scanning calorimetry and X-ray powder diffractometry. The optimized formulation was subjected to accelerated stability testing as per ICH guidelines. Release data were examined kinetically. SD with 1:4 and 1:5 ratio of drug to polymer obtained by solvent evaporation and cogrinding were selected as the best candidates suitable for prolonged-release oral dosage form of metformin.
  2 4,157 347
PHARMACEUTICAL ANALYSIS
Development and validation of a specific stability indicating high performance liquid chromatographic method for valsartan
KS Rao, N Jena, MEB Rao
April-June 2010, 2(2):183-189
DOI:10.4103/0975-1483.63166  PMID:21264123
A stability-indicating HPLC assay method has been developed and validated for valsartan in bulk drug and pharmaceutical dosage forms. An isocratic RP-HPLC was achieved on Waters 2695 using Symmetry C18 (250mm Χ 4.6mm Χ 5΅) column with the mobile phase consisting of 0.02 mM sodium dihydrogen ortho-phosphate, pH adjusted to 2.5 using ortho-phosphoric acid (solvent A), and acetonitrile (solvent B) in the ratio of 58:42 %v/v. The stress testing of valsartan was carried out under acidic, alkaline, oxidative, thermal, and photolytic conditions. Valsartan was well resolved from its degradation products. The proposed method was validated as per ICH guidelines. The method was found to be suitable for the quality control of valsartan in bulk and pharmaceutical dosage forms as well as the stability-indicating studies.
  1 2,487 161
Comparative study of RP-HPLC and UV spectrophotometric techniques for the simultaneous determination of amoxicillin and cloxacillin in capsules
Do T Giang, Vu D Hoang
April-June 2010, 2(2):190-195
DOI:10.4103/0975-1483.63168  PMID:21264124
Reversed-phase HPLC and UV spectrophotometric techniques using water as solvent have been developed and validated for the simultaneous determination of amoxicillin and cloxacillin in capsules. For both techniques, the linearity range of 60.0-140.0 ΅g/mL was studied. The spectrophotometric data show that non-derivative techniques, such as absorbance ratio and compensation, and ratio spectra first-order derivative could be successfully used for the co-assay of amoxicillin and cloxacillin. Based on the statistical comparison of spectrophotometric and chromatographic data, the interchangeability between HPLC and UV spectrophotometric techniques has been suggested for the routine analysis.
  - 4,156 140
PHARMACY PRACTICE
In vivo and In vitro drug interactions study of glimepride with atorvastatin and rosuvastatin
VJ Galani, M Vyas
April-June 2010, 2(2):196-200
DOI:10.4103/0975-1483.63169  PMID:21264125
Aim of this investigation was to study the in vivo and in vitro drug interaction of glimepride with atorvastatin and rosuvastatin. In vitro drug interaction of glimepride with atorvastatin and rosuvastatin was studied using human pooled liver microsomes and evaluated using high performance liquid chromatography. In vivo pharmacokinetic drug interaction of glimepride (6 mg/kg) in coadministration with atorvastatin (60 mg/kg) and rosuvastatin (60 mg/kg) were studied in rats and analyzed using liquid chromatography tandem mass spectrometry (LC-MS/MS). In in vitro study, atorvastatin decreased its own metabolism as well as the metabolism of glimepiride. Rosuvastatin coadministration with glimepride reduced the metabolism of glimepride and increased the metabolism of its own. In in vivo study, concentration in plasma, C max , AUC (0-t) and AUC (0-∞) (area under the concentration-time curve, AUC) of glimepride was increased significantly in coadministration with atorvastatin whereas there was no significant change was observed in the case of coadministration with rosuvastatin. Half life (T 1/2 ) and volume of distribution (V d ) of glimepride decreased significantly with both atorvastatin and rosuvastatin. Elimination rate constant, K el of glimepride increased significantly with both atorvastatin and rosuvastatin. Clearance (Cl) of glimepride decreased significantly but the decrease was more with atorvastatin than with rosuvastatin. It is concluded that glimepride metabolism is little affected by rosuvastatin in vitro, which agreed with the negligible interaction in in vivo study. Thus, from safety point of view rosuvastatin is better to prescribe as a coadministration therapy with glimepiride. On the other hand, atorvastatin could cause an increase in the bioavailability of glimepride per oral and also significantly decrease the metabolism of glimerpride in in vitro study. This may pose a positive implication in clinical practice.
  - 2,929 150
PHARMACEUTICAL MANAGEMENT
ABC and VED analysis of the pharmacy store of a tertiary care teaching, research and referral healthcare institute of India
M Devnani, AK Gupta, R Nigah
April-June 2010, 2(2):201-205
DOI:10.4103/0975-1483.63170  PMID:21264126
The ABC and VED (vital, essential, desirable) analysis of the pharmacy store of Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, was conducted to identify the categories of items needing stringent management control. The annual consumption and expenditure incurred on each item of pharmacy for the year 2007-08 was analyzed and inventory control techniques, i.e. ABC, VED and ABC-VED matrix analysis, were applied. The drug formulary of the pharmacy consisted of 421 items. The total annual drug expenditure (ADE) on items issued in 2007-08 was Rs. 40,012,612. ABC analysis revealed 13.78%, 21.85% and 64.37% items as A, B and C category items, respectively, accounting for 69.97%, 19.95% and 10.08% of ADE of the pharmacy. VED analysis showed 12.11%, 59.38% and 28.51% items as V, E, and D category items, respectively, accounting for 17.14%, 72.38% and 10.48% of ADE of the pharmacy. On ABC-VED matrix analysis, 22.09%, 54.63% and 23.28% items were found to be category I, II and III items, respectively, accounting for 74.21%, 22.23% and 3.56% of ADE of the pharmacy. The ABC and VED techniques need to be adopted as a routine practice for optimal use of resources and elimination of out-of-stock situations in the hospital pharmacy.
  - 12,804 272
GENERAL PHARMACY
Recent trends on the future of graduate education in the pharmaceutical sciences and research
KSS Kushwaha, N Kushwaha, AK Rai
April-June 2010, 2(2):206-212
DOI:10.4103/0975-1483.63173  PMID:21264127
Harmonization of pharmacy education has to be made a global agenda that will encompass the developments that have taken place in basic, medical, pharmaceutical sciences in serving the needs and expectations of the society. The professional pharmacy curriculum is designed to produce pharmacists who have the abilities and skills to provide drug information, education, and pharmaceutical care to patients; manage the pharmacy and its medication distribution and control systems; and promote public health. Required coursework for all pharmacy students includes pharmaceutical chemistry; pharmaceutics (drug dosage forms, delivery, and disposition in the human body) pharmacology; therapeutics (the clinical use of drugs and dietary supplements in patients); drug information and analysis; pharmacy administration (including pharmacy law, bioethics, health systems, pharmacoeconomics, medical informatics); clinical skills (physical assessment, patient counseling, drug therapy monitoring for appropriate selection, dose, effect, interactions, use); and clinical pharmacy practice in pharmacies, industry, health maintenance organizations, hospital wards, and ambulatory care clinics.
  - 1,994 109
EDITORIAL
Conflict of Interest in peer-reviewed medical journals: The world association of medical editors position on a challenging problem
LE Ferris, RH Fletcher
April-June 2010, 2(2):113-115
DOI:10.4103/0975-1483.63143  PMID:21264111
  - 922 123
PHARMACEUTICS
Studies on In situ hydrogel: A smart way for safe and sustained ocular drug delivery
DH Shastri, LD Patel, RK Parikh
April-June 2010, 2(2):116-120
DOI:10.4103/0975-1483.63144  PMID:21264112
The present work describes the formulation development of ophthalmic in situ gelling system using thermo-reversible gelling polymer, i.e. Pluronic F 127 (PF127). Because of high concentration (20 to 25%w/v) of this polymer required for in situ gelation causes irritation to the eye. So, to reduce this concentration, an attempt was made to combine the PF127 with other polymers like hydroxy propyl methyl cellulose (HPMC) as a viscosity increasing agent or with polymers like carbopol 940, xanthan gum, and sodium alginate (high glucuronic acid content) showing a pH and cation-triggered sol-gel transition, respectively. Different batches were prepared of varying concentrations of these polymers with PF127 using cromolyn sodium 2%w/v in phosphate buffer pH 5.0. The formulations were optimized by the viscosity measurement and in vitro gelation study. Selected formulations were evaluated for in vitro drug release profile and indicated sustain drug release over a period of 10 h. Effect of sterilization on drug content, pH, clarity, and viscosity were also evaluated. Finally, we concluded that by using this type of combination system, we could reduce not only the concentration of individual polymers but also the side effects without compromising the in vitro gelling capacity as well as overall rheology of the system.
  - 2,875 291
PHARMACOGNOSY
Aqueous extract of Ficus bengalensis linn. bark for inflammatory bowel disease
MA Patel, PK Patel, MB Patel
April-June 2010, 2(2):130-136
DOI:10.4103/0975-1483.63149  PMID:21264114
The present study was designed to evaluate the effects of aqueous extract of Ficus bengalensis Linn. bark (AEFB) on inflammatory bowel disease (IBD). Effects of AEFB were studied on 2, 4, 6-trinitrobenzenesulfonic acid (TNBS, 0.25 ml 120 mg/ml in 50% ethanol intrarectally, on first day only)-induced IBD in rats. Effects of co-administration of prednisolone (2 mg/kg) and AEFB (250, 500 mg/kg) for 21 days were also evaluated. Various physical parameters including body weight, food, and water intake measured on 1st and 21st days. At end of the experiment, various histopathological indexes are assessed. The colon homogenate malondialdehyde (MDA), myeloperoxidase (MPO), superoxide dismutase (SOD), and nitric oxide (NO) levels and % mast cell protection in mesentery were also measured. In our study, we found that AEFB has a significant protective effect in the inflammatory bowel disease as compared to prednisolone in rats.
  - 1,469 155
Antioxidant, antinociceptive and anti-inflammatory activities of ethanolic extract of leaves of Alocasia indica (Schott.)
WA Mulla, SB Kuchekar, VS Thorat, AR Chopade, BS Kuchekar
April-June 2010, 2(2):137-143
DOI:10.4103/0975-1483.63152  PMID:21264115
Extracts obtained from the leaves of various Alocasia species have been used in India as folk remedy for the treatment of various inflammatory ailments including rheumatism and bruise. The ethanolic extract of leaves of Alocasia indica Schott. was evaluated by using different in vitro antioxidant models of screening like scavenging of 1, 1-diphenyl-2-picryl hydrazyl (DPPH) radical, nitric oxide radical, superoxide anion radical, and hydroxyl radical. The antinociceptive activity was tested by acetic acid-induced writhing response, hot plate method, and tail flick method in albino rats. The anti-inflammatory potential of gels of ethanolic extract has been determined by using carrageenan-induced paw edema assay, formalin-induced paw edema assay, arachidonic acid-induced ear edema assay, and xylene-induced ear edema assay. The extract showed remarkable antioxidant activity in all models, comparable to the standard reference drug ascorbic acid. The ethanolic extract of Alocasia indica and its gels produced dose-dependent antinociceptive and anti-inflammatory activity, respectively. This finding suggests that ethanolic extract of A. indica possess potent antinociceptive and anti-inflammatory activity possibly due to its free radical scavenging properties.
  - 2,253 138
PHARMACOLOGY
Glucagon secreting cells responds to insulin secretion In vitro using immunocytochemistry
MK Aswar, UM Aswar, NK Subhedar
April-June 2010, 2(2):144-147
DOI:10.4103/0975-1483.63154  PMID:21264116
In the present study, pancreas of rats were dissected and transferred to HEPES buffer (25 mM, pH 7.4). The control tissue pieces were kept in culture medium for one hour and the treated tissues were kept in same medium for 30 minutes and incubated with Insulin (10 nm and 100 nm) for another half hour, then tissues were transferred to Bouin's fixative (overnight at 40°Cc), cryosectioned (15 μm at -16 0 c) and subjected to immunocytochemical labeling with antibodies against Glucagon. Results: In the sections of control tissue, the Glucagon Immunoreactive Cells (GIC) were distinctly visible; on average 40-50 cells were counted in each islet. However in vitro treatment with 10 nm insulin caused 285.89 % increase in the GIC and was found to be highly significant (P<0.001). Whereas in 100 nm Insulin treatment, 206.41% increase in GIC was seen, this was significant with the control but non-significant with 10 nm Insulin treatment
  - 792 45
Possible role of hydrogen sulfide in insulin secretion and in development of insulin resistance
MA Patel, GB Shah
April-June 2010, 2(2):148-151
DOI:10.4103/0975-1483.63156  PMID:21264117
H 2 S has been proposed as physiological important molecule. It is considered as first endogenous gaseous K + channel opener. K + ATP channel activity is mainly responsible for insulin secretion. K +ATP channel opening of β cells leads to inhibition of insulin secretion and channels closing leads to secretion. H2S is the gaseous K + ATP channel opener but it does not have channel specificity. So, H 2 S may have some effect on insulin secretion. H 2 S is high in Zuker diabetic fatty rats. That means H 2 S is high in insulin resistance condition. We tried to find out the role of H 2 S in insulin secretion and in development of insulin resistance. From the result of our study, H 2 S have K + ATP channel opening activity on β cells. H2 S does not have any role in the development of insulin resistance. Decrease in insulin level in Zuker diabetic rat and streptozotocin-induced diabetic rat is due to high H 2 S level.
  - 1,124 65
Drug-drug interaction between pravastatin and gemfibrozil (antihyperlipidemic) with gliclazide (antidiabetic) in rats
CM Sultanpur, S Satyanarayana, NS Reddy, KE Kumar, S Kumar
April-June 2010, 2(2):152-155
DOI:10.4103/0975-1483.63157  PMID:21264118
Diabetes mellitus is a condition of increased blood glucose level in the body. Antihyperlipidemic drugs like statins and fibrates are widely used for prophylactic treatment in dyslipideamia and atherosclerosis. Diabetic dislipidemia exists with increased triglycerides, low HDL and high LDL levels. Hence, with oral hypoglycemic drugs, the addition of a lipid-lowering drug is necessary for controlling dislipidemia. In such a situation, there may be chances of drug-drug interactions between antidiabetic and antihyperlipidemic drugs. The present study is planned to evaluate the safety of gliclazide (antidiabetic) in the presence of pravastatin and gemfibrozil (antihyperlpidemic) in rats. Studies in normal and alloxan-induced diabetic rats were conducted with oral doses of gliclazide and their combination with pravastatin and gemfibrozil, with an adequate washout period in between the treatments. Blood samples were collected in rats by retroorbital puncture at 0, 1, 2, 3, 4, 6, 8, 10 and 12 h. All the blood samples were analyzed for glucose by GOD -POD. Gliclazide (½ TD) produced hypoglycemic activity in normal and diabetic rats, with peak activity at 2 and 8 h. Pravastatin (TD) + gemfibrozil (TD) combination treatment increased the hypoglycemic effect of gliclazide in normal rats or diabetic rats when administered together. The interaction observed due to inhibition of both the enzymes (CYP 450 2C9 and CYP 450 3A4) responsible for the metabolism of gliclazide showed increased half-life, which was seen in the present study. Because concomitant administration of gliclazide with provastatin and gemfibrozil in diabetes is associated with atherosclerosis, it should be contraindicated or used with caution.
  - 2,665 106
A novel approach for oral delivery of insulin via Desmodium gangeticum aqueous root extract
GA Kurian, AV Seetharaman, NR Subramanian, J Paddikkala
April-June 2010, 2(2):156-161
DOI:10.4103/0975-1483.63158  PMID:21264119
Many challenges are associated with the oral delivery of insulin, relating to the physical and chemical stability of the hormone, and its absorption and metabolism in the human body. The present study aims to demonstrate the oral delivery of insulin in both normal and steptozotocin (STZ)-induced diabetic rats with the help of the aqueous extract of Desmodium gangeticum (DG) root. Human insulin was mixed with the aqueous extract of DG root (0.1 mg/ml) with human insulin (40 IU/ml) in ratio 1:1(v/v), to prepare oral insulin drug. Decreased plasma glucose level and increased plasma insulin in normal and STZ-induced diabetic rat suggested the probable absorption of insulin through GI tract when insulin was administered by mixing with DG extract. Indeed, insulin mixed DG potentially stimulates the release of insulin in STZ-induced diabetic rat rather than in normal animal. In vivo insulin secretaguage action of oral insulin drug was determined by isolated rat heart model and the results showed a significant cardio protection in STZ rat. The finding of this study suggests that insulin mixed with DG extract can be a promising vehicle for oral delivery of insulin. However, further studies are required to explore the exact compound(s) responsible for the protective delivery of insulin orally. Increased plasma insulin level by insulin mixed DG extract administration in STZ-treated diabetic rat indicates not only insulin secretaguage action of the mixture but also a probable altered insulin release mechanism in diabetic condition.
  - 1,238 91
PHARMACEUTICAL CHEMISTRY
Synthesis and pharmacological evaluation of novel schiff base analogues of 3-(4-amino) phenylimino) 5-fluoroindolin-2-one
R Nirmal, CR Prakash, K Meenakshi, P Shanmugapandiyan
April-June 2010, 2(2):162-168
DOI:10.4103/0975-1483.63162  PMID:21264120
In our study, a series of novel 3-(4-(benzylideneamino) phenylimino) 4-fluoroindolin-2-one derivatives were synthesized and characterized by spectral (I.R, 1 H NMR, mass) and elemental analysis. The title compounds (N 1 -N 10 ) were evaluated for analgesic, anti-inflammatory, and ulcerogenic index activities. Results displayed that compound N 3 exhibited significant analgesic activity. Among the title compounds studied, N 2 , N 3 , and N 8 exhibited significant anti- inflammatory activity comparable to reference standard diclofenac sodium. Interestingly, the test compounds showed only mild ulcerogenic side effect when compared to aspirin.
  - 1,941 137
Synthesis and evaluation of 1,3 Di-substituted schiff, mannich bases and spiro isatin derivatives
P Mondal, M Banerjee, S Jana, A Bose
April-June 2010, 2(2):169-172
DOI:10.4103/0975-1483.63164  PMID:21264121
Schiff bases of isatin with aminothiazole, its N-mannich bases and Spiro isatin derivatives were synthesized. Their chemical structures were confirmed by Infrared, 1H-Nuclear Magnetic Resonance data and elemental analysis. Antimicrobial evaluation was performed by the agar diffusion method against four pathogenic bacteria and two pathogenic fungi. Anti-inflammatory activity was tested by carragenin-induced rat paw edema and compounds were evaluated for analgesic action by the acetic acid-induced writhing method; Compounds Aa, Ab and A5, A6 were found to be active against bacteria and fungi. The compounds A3, A6, Aa and Ab showed anti-inflammatory activity, having a percentage protection value of 34.69, 32.65, 38.77 and 36.73 as compared with that of indomethacin, with % protection of 46.93. Similarly, the compounds Aa, Ab and A6 showed analgesic activity, with % protection of 67.51, 64.78 and 49.81 as compared with the standard with % protection of 79.56.
  - 1,725 129
Synthesis and antimicrobial activity of 2-[2-(2,6-dichloro phenyl)amino]benzyl-3-(5-substituted phenyl-4,5-dihydro-1H-pyrazol-3-yl-amino)-6,8-dibromoquinazolin-4(3H)ones
NB Patel, JC Patel, GG Barat
April-June 2010, 2(2):173-182
DOI:10.4103/0975-1483.63165  PMID:21264122
A series of 2-[2-(2,6-dichlorophenyl)amino]benzyl-3-(5-substituted phenyl-4,5-dihydro-1H-pyrazol-3-yl-amino)-6,8-dibromoquinazolin-4(3H) ones 6a-m have been synthesized by the reaction of 2-[2-(2,6-dichlorophenyl)amino]benzyl-3-substituted phenylacrylamido-6,8-dibromoquinazolin-4(3H) ones 5a-m with hydrazine hydrate in the presence of glacial acetic acid. The chalcones 5a-m were prepared by the condensation of 2-[2-(2,6-dichlorophenyl)amino]benzyl-3-acetamido-6,8-dibromoquinazolin-4(3H)one 4 with different substituted aromatic aldehyde. The benzoxazinone 2 was synthesized from 2-[2-(2,6-dichlorophenyl)amino]phenyl acetyl chloride 1 on treatment with 3,5-dibromoanthranilic acid in pyridine, which on reaction with hydrazine hydrate and then on acetylation reaction yielded 4. The structures of these compounds have been elucidated by elemental analyses, IR, and NMR spectral data. The title compounds pyrazolyl-quinazolin-4(3H)ones 6a-m were evaluated for their antibacterial and antifungal activities in vitro.
  - 1,706 163
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