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A STUDY ON DRUG UTILIZATION PATTERN AND EFFECTIVENESS OF ORAL HYPOGLYCEMIC AGENTS IN DIABETES MELLITUS
Alti Aparna1*, Seema Pushpa Latha1, Gopalgari Lakshmi Nagarjun1, Galammagari Nagaraju1, C. Gopinath1, P. Murali Madhav2
1Annamacharya College of Pharmacy, Kadapa, Andhra Pradesh.
2Rajiv Gandhi Institute of Medical Science, Kadapa, Andhra Pradesh.
Introduction: Diabetes mellitus is on alarming rise in India. Drug utilization studies help to identify the adherence to standard guidelines and extent of drug use and to evaluate the rational drug usage.
Aims and objectives: To determine the drug utilization pattern and effectiveness of oral hypoglycemic agents among diabetes mellitus patients.
Materials and methods: It is a prospective observational study carried out for a period of six months at RIMS kadapa, and two others diabetic centers. The diabetic patients who visited the medicine outpatient department were included. After obtaining approval from institutional ethical committee, a structured data collection form was used to collect demographic data, complete prescription details and other relevant information required for the study. The drug utilization pattern was determined. The drugs were categorized by Anatomical therapeutic classification (ATC) and DDD/1000 inhabitants/day was calculated by using WHO guidelines. Among all oral hypoglycemic agents the most effective drug/combination in this region was identified.
RESULTS: 716 prescriptions were assessed out of which,401(56.0%) were females and 315(43.9%) were males, most of the patients were in the age group of 40-60 for males 175(55%) and females 205(51.1%). Hypertension was the most common co-morbid seen. The average number of drugs per prescription was 4.26 and anti-diabetics per prescription was 1.79. DDD/1000 inhabitants/day for metformin (A10BA02) was 10.5, glimiperide (A10BB12) was 9.3, glibenclamide (A10BB01) was 7.91, pioglitazone (A10BG03) was 7.25. Out of 716 patients 311(45.25%) patients were on Monotherapy, and 405 (56.5%) were on Combination therapy.A total of 200 newly diagnosed patients of diabetes mellitus were enrolled in the study out of which only 128 members were followed up successfully. The combinations of Metformin +Sulfonyl Ureas + Others showed a good control of fasting blood sugar when compared with only Metformin, only Sulfonyl Ureas or Metformin +Sulfonyl Ureas, Sulfonyl Ureas + Others.
Conclusion: Metformin was the most utilized drug followed by glimiperide. Combination therapy was most frequent when compared to monotherapy in which metformin+glimiperide was commonly prescribed one. so by understanding the current prescribing patterns attempts can be made to improve rational prescribing. The combination of Metformin+Sulfonyl Ureas+Others is more effective combination.
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF LAMOTRIGINE AND CLOZAPINE IN SYNTHETIC MIXTURE BY ABSORPTION CORRECTION METHOD
Priyanka P. Atodariya*, Hasumati A. Raj, Vineet C. Jain
*Shree Dhanvantary Pharmacy Collage, Kim,
Surat, Gujarat, India
The simple spectroscopic method has been developed for simultaneous estimation of Lamotrigine and Clozapine in synthetic mixture. Absorption Correction Method involves the measurement of absorption at two wavelengths 307 nm (lmaxfor Lamotrigine) and 360 nm (lmax for Clozapine). The method was found linear between the range of 1-5 µg/ml for Lamotrigine and 6-30 µg/ml for Clozapine for method .The accuracy and precision was determined and validated statistically. Both the method showed good reproducibility and recovery with %RSD less than 1. The method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis for Lamotrigine and Clozapine in bulk and combined dosage form.
ANTICONVULSANT EFFECT OF LEAF AND BARK OF ERYTHRINA VARIEGATA LINN AND BUTEA MONOSPERMA (LAM) TAUB IN DIFFERENT EXPERIMENTAL CONVULSION MODEL IN RATS
Prakash T. Sangale*1, Dhananjay B. Deshmukh2, Rajesh Bhambere3
1Department of Quality Assurance Techniques,
2Department of Pharmacology,
VJSM’S Vishal Institute of Pharmaceutical Education and Research,
Ale, Junnar, Pune
Epilepsy is a chronic disorder characterized by the occurrence of epileptic seizures, with or without characteristic body movements (convulsion)affecting about 50 million people worldwide. Synthetic drugs for the treatment of epilepsy are associated with severe side effects and addiction liabilities upon long term uses. Thus, researchers around the globe are searching for natural resources.Erythrinavariegata and Butea monosperma is a traditional medicinal plant used to treat a seizure.The present studies reveal that the anticonvulsant activity by Erythrina variegate & Butea monosperma of bark & leaf PTZ and MES induced convulsions in wistar rats using Erythrina variegata & Butea monosperma of bark & leaf ethanolic extracts extracted successively. However, the anticonvulsant activity of this plant has not been studied in depth.
In Pentylene tetrazole (PTZ) an maximal electro shock seizure(MES) models test parameters like latncy, onset of tonic convulsions, clonic convulsions and percent protection were observed in the different test groups. Inconclusion, we showed that the ethanolic extract of Erythrina variegata and Butea monosperma has anticonvulsant effect in the both models, suggesting their possible depressant action in the central nervous system. EEBM and EEEV gave significant protection (P<0.001) against PTZ & MES induce convulsion.
SIMULTANEOUS DETERMINATION OF ITOPRIDE HYDROCHLORIDE AND LANSOPRAZOLE IN SYNTHETIC MIXTURE USING SPECTROPHOTOMETRIC TECHNIQUE (FIRST ORDER DERIVATIVE METHOD
*Ashif I. Bhim1, Farhana V. Buchiy1, Hasumati A. Raj1, Vineet C. Jain2
1Department of Qaulity Assurane, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, India.
2Department of Pharmacognocy, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, India.
A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Itopride Hydrochloride and Lansoprazole in synthetic mixture using first order derivative zero-crossing method. Itopride Hydrochlorideshowed zero crossing point at 278.12nmwhile Lansoprazole showed zero crossing point at 244.58nm. The dA/dλ was measured at 244.12 nm for Itopride Hydrochloride and 278.12nmfor Lansoprazole and calibration curves were plotted as dA/dλ versus concentration, respectively. The method was found to be linear (r2>0.999) in the range of 5-25μg/ml for Itopride Hydrochloride at 244.58nm. The linear correlation was obtained (r2>0.996) in the range of 5-25 μg/ml for Lansoprazole at 278.12 nm. The limit of determination was 0.155μg/ml and 0.059μg/ml forItopride Hydrochloride and Lansoprazole, respectively. The limit of quantification was 0.472μg/ml and 0.179μg/ml for Itopride Hydrochloride and Lansoprazolerespectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99% shows first order derivation zero crossing. The method was successfully applied for simultaneous determination of Itopride Hydrochloride and Lansoprazolein binary mixture.
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF AMITRIPTYLINE HYDROCHLORIDE AND METHYLCOBALAMIN IN THEIR TABLET DOSAGE FORM BY UV SPECTROPHOTOMETRIC METHOD
Chetna V. Karchaliya*, Parula B. Patel
Department of Quality Assurance,
S. J. Thakkar Pharmacy College,
Rajkot, Gujarat, India
The simple, accurate and precise Absorption Correction Method has been developed for the simultaneous estimation of Amitriptyline hydrochloride and Methylcobalamin in combined tablet dosage form. The method utilizes distilled water as solvent and λmax of Amitriptyline hydrochloride and Methylcobalamin selected for analysis were found to be 239 nm and 351 nm respectively. The method was validated as per International Conference on Harmonization (ICH) guidelines. The Linearity range lies between 20-60 µg/ml (R2 0.9998) for Amitrityline hydrochloride and 3-9 µg/ml (R2 0.9990) for methylcobalamin. The accuracy and precision were determined and found to comply with ICH guidelines. The method showed good reproducibility and recovery with %RSD in desired range. The proposed method can be applied for routine analysis of both drugs.
Nidha Amir*, Mohd Mazhar, Abhinav Sawhney, S.K Rajput
Department of Pharmacology
Amity Institute of Pharmacy, Amity University, NOIDA, Uttar Pradesh-201313, India
Fluorine, the 13th most abundant element of the earth’s crust, represents about 0.3g / kg of earth’s crust. It occurs mainly in the form of chemical compounds such as sodium fluoride or hydrogen fluoride, which are present in minerals fluorospar, fluorapatite, topaz and cryolitect. Fluoride is frequently encountered in minerals and in geochemical deposits and is generally released into subsoil water sources by slow natural degradation of fluorine contained in rocks. Fluoride being a natural element has several effects on health. Fluoride is beneficial to health if the concentration (CF) of the fluoride ion (F-) in drinking water is less than 1.5 mg/L (WHO 1994). A higher concentration causes serious health hazards. The disease caused manifests itself in three forms, namely, dental, skeletal, and non-skeletal fluorosis. On a large scale, it is used in dental product due to its anti- sensitizing property and abrasive action. Application of fluoride must be controlled and restricted to reduce the side effect induced by it.
Sagar Alone*, Sharda Deore, Bhushan Bawiskar
Department of Pharmacognosy & Phytochemistry
Govt. College of pharmacy, Kathora naka, Amravati-444604, India
Total seventeen saponins previously isolated from roots of Pulsatilla koreana having cytotoxic activity against 4 different cancer cell line (A-549, SK-OV-3, SK-MEL-2, HCT15) were used for 2D QSAR using V-life Molecular design suit. Using multiple linear regression method against 4 different cell lines develops QSAR model. QSAR model was generated by using training set of 11 and test set of 6 molecules having correlation coefficient (r2), significant cross validated correlation coefficient (q2) and F-test (For statistical significance) is as given below (A-549: r2- 0.9281, q2- 0.8691, F-test- 51.6079), (SK-OV-3: r2- 0.9554, q2- 0.9184, F-test- 85.7357), (SK-MEL-2: r2- 0.9160, q2- 0.8285, F-test- 43.6084), (HCT15: r2- 0.9203, q2- 0.8357, F-test- 46.1887). In this QSAR study Alignment independent descriptors such as T_2_C_7, T_O_O_5 and physicochemical descriptors like Chain path count such as 6 chain count and Chi chain such as Chi 6 chain were most responsible descriptors for anticancer activity.
Somsubhra Ghosh1*, B. V. V. Ravikumar2, B. Mahanti1
1Bharat Technology, Banitabla, Uluberia, West Bengal
2Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha
Validation is a very important tool in GMP. Main aim & objective of GMP to all Pharmaceutical agencies are to provide a good & reasonable quality of Pharmaceutical products to people. To get that desired quality Validation is great support to all Pharmaceutical & other industry people. Validation is also a very important tool to save money, time, labourer, waste material etc. There are different types of Validation used all over the world by which we can achieve our goal very easily. In this review it is briefly described scope, importance, objectives & types of Validation as per international norms. Now days it became so important that without validation any process, method or instrument are not accepted globally.
ABSORBANCE CORRECTION METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND SIMVASTATIN IN SYNTHETIC MIXTURE
Vandana M Patel*, Hasumati A Raj, Vineet C Jain
*Shree Dhanvantary College of Pharmacy,
Kim, Surat, Gujarat, India.
A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Amlodipine besylate and Simvastatin in synthetic mixture using Absorbance correction method. At 360.80 nm (λmax of Amlodipine besylate) Simvastatin has zero absorbance so Amlodipine besylate is directly estimate at 360.80 nm. At 237.60 nm (λmax of Simvastatin) both drugs have some absorbance so Simvastatin is estimate at 237.60 nm using absorbance correction method. The method was found to be linear (r2>0.999) in the range of 5-10 μg/ml for Amlodipine besylate at 360.80 nm. The linear correlation was obtained (r2>0.999) in the range of 5-10 μg/ml for Simvastatin at 237.60 nm. The limit of determination was 0.17 μg/ml and 0.10μg/ml for Amlodipine besylate and Simvastatin, respectively. The limit of quantification was 0. 54μg/ml and 0. 32μg/ml for Amlodipine besylate and Simvastatin, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99%. The method was successfully applied for simultaneous determination of Amlodipine besylate and Simvastatin in binary mixture.
ZERO ORDER AND AREA UNDER CURVE SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF FLUOXETINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION
Mali Audumbar*, Jadhav Santosh, Hake Gorakhnath, Tamboli Ashpak
Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade,
Sangola-413307, Solapur, Maharashtra, India.
Simple, fast and reliable spectrophotometric methods were developed for determination of Fluoxetine Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the zero order derivative values measured at 226 nm and the area under the curve method values measured at 220-231 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Fluoxetine Hydrochloride using 5-25μg/ml (r²=0.999 and r²=0.997) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Fluoxetine Hydrochloride in tablets.