IAJPR

Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
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DECEMBER 2017
1

A CASE SERIES ON AMLODIPINE INDUCED EDEMA

Sreeram Vandavasi Guru*1, Araveti Lokesh1, P. Gowtham Reddy2

1Rajiv Gandhi Institute of medical sciences (RIMS), PRRMCP, Kadapa, India -516003.

2Dept. of Pharmacy Practice, PRRMCP, Kadapa, India- 516003.

Hypertension is one of the most common clinical conditions encountered by the physicians. There are wide ranges of medications available for treatment of hypertension, in which Calcium Channel Blockers (CCBs) are one of the most commonly prescribing drugs. CCBs are potential antihypertensive agents but the main drawback of this group of drugs is it produces pedal edema which decreases the compliance. The main cause for CCB-induced edema is increased capillary hydrostatic pressure by arteriolar dilation. Amlodipine is a third generation calcium channel blocker used in adults and children above 6 years old for the treatment of hypertension, angina and other coronary artery diseaseThe drug exhibits constant pharmacokinetics and pharmacodynamics and well tolerated but has more incidence of pedal edema than the other calcium channel blockers often leading to noncompliance and discontinuation of drug. This review article is aiming to explain the calcium channel blocker in particular amlodipine - associated edema and resolution of edema through the use of other hypertensive agents. Here we present 5 cases of different age group patients diagnosed with hypertension, type II diabetes mellitus, hemorrhagic stroke, CVA and gastritis who gradually developed pitting type pedal edema after the initiation of oral Amlodipine of dose 5 mg. The symptoms improved on cessation of amlodipine and the patient was managed with an alternative antihypertensive agents. Here, we set up the relationship between the suspected drug and the adverse reaction observed by performing causality assessment. The early detection, discontinuation of offending drug and prescription of alternative hypertensive agent improves patient’s condition and restores normal quality of life.

2

PHYTOCHEMICAL AND ANTHELMINTIC SCREENING OF MORINGA OLEIFERA STEM ETHANOLIC EXTRACT

Mohammed Sayeed, Dr. Vasudha Bakshi, Narender Boggula*

Department of Pharmacology, School of Pharmacy, Anurag Group of Institutions, Venkatapur, Ghatkesar, Telangana, India.

Helminthic infections are the most common infection in human beings affecting a large proportion of the world’s population. Antihelminthic (Anthelmintic) drugs are the drugs which are used to kill or reduce the number of helminthic parasites in the intestinal tract or tissues of the body. Moringa oleifera belonging to the moringaceae family is a highly valued plant, distributed in many countries of the tropical and subtropical. The standard drugs such as piperazine citrate, albendazole, mebendazole and thiabendazole possess some side effects such as nausea, vomiting, stomach and abdominal pain, headache, dizziness, and temporary hair loss etc. But the herbal drug shows fewer side effects. The plant which shows muscle relaxant property may also shows antihelminthic activity. So we have selected Moringa oleifera which is an herbal drug and shows muscle relaxant property. Hence the present study was undertaken for phytochemical evaluation and to test the antihelminthic activity of ethanolic extract of Moringa oleifera stem. Preliminary phytochemical investigation indicates the presence of alkaloids, glycosides, flavonoids, steroids, carbohydrates and tannins. Indian adult earthworms (Pheretima posthuma) were used to study antihelminthic activity. The activity was checked in ethanolic extract with three different concentrations (100, 200, and 400mg/ml) and compared with the standard drug albendazole (40mg/ml) and control as distilled water. The result was expressed in the terms of paralysis time and death time of worms. Ethanolic extract of Moringa oleifera stem shows antihelminthic activity in dose dependent manner and maximum efficacy is seen at 400mg/ml concentration. Hence it was concluded that ethanolic extract of Moringa oleifera stem have antihelminthic activity.

3

“IDENTIFICATION AND EVALUATION OF DRUG RELATED PROBLEMS AND ITS PREVALENCE IN MEDICAL AND EMERGENCY WARD OF ATERTIARY CARE TEACHING HOSPITAL”

D.Amrutha, Johnson Feba, Mathew Nissy, Sam.K.Gloria*

Department of Pharmacy Practice, Bapuji Pharmacy College, Davangere, Karnataka, India.

According to the Pharmaceutical Care Network Europe Foundation (PCNE) classification, “A Drug-Related Problems (DRPs) is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes.” DRPs might result in reduced quality of life, prolonged hospital stay and even raises the risk of morbidity and mortality. A clinical pharmacist plays a significant role in reviewing the prescriptions for drug- related problems. This in turn provides a channel for clinical intervention, thereby improving patient’s quality of care. The prospective, observational, Interventional study focused to identify, evaluate and study the prevalence of drug related problems in medical and emergency unit of a tertiary care teaching hospital. A total of 202 cases was analyzed for DRPs, in which males were prominent 58.91% than females 41.09%. In this study, patients of age group 41-60 years (39.60%) were prevailing. Out of 202 cases, 182 cases were identified with DRP and 20 cases without DRPs. Drug-Drug interactions (67.13%) were the top ranking DRP. Loop diuretics were the common class of drugs involved in DRPs. There was an association between age, poly-pharmacy and length of hospital stay with DRPs. The prevalence of DRP was 90.10%. Interventions were proposed for every DRPs identified. This study demonstrates the importance of clinical pharmacy services in enhancing patient’s health care by decreasing the frequency of occurrence of drug related problems.

4

DESIGN AND DEVELOPMENT OF SELF MICROEMULSIFYING DRUG DELIVERY SYSTEM OF LURASIDONE HCl

Komal Rahevar*, Dr. Mukesh R. Patel, Dr. Kanu R. Patel

Gujarat Technological University, Gujarat.

Shri B. M. Shah College of Pharmaceutical Education and Research, College Campus, Dhansura Road, Modasa- 383 315. (Arvalli) Gujarat, India.

Objective: Lurasidone HCl is poorly water soluble drug. It should be come in to the BCS Class II drug. Hence oral Bioavailability of Lurasidone HCl is less (9-19%). To develop novel dosage foam of the self-Microemulsifying drug delivery systems (SMEDDS) for the Lurasidone HCl for enhancing its solubility hence the oral bioavailability. Methods: Solubility study was performed in different excipient and selected excipient on basis of solubility of Lurasidone HCl. Self microemulsion region was decided by preparing construction phase diagram. Drug excipient interaction study using FTIR. SMEDDS formulation was prepared in Capryol 90 (oil), Acrysol K-140(surfactant), and Transcutol P (co-surfactant) by simple mixing at 25°C. Parameters evaluated included: macroscopic evaluation, visual assessment, self-emulsification, transmittance test, particle size distribution, zeta potential and polydispersity index and In vitro dissolution. In-Vitro dissolution was carried in USP apparatus II using pH 1.2 HCl buffer at 37±0.5°C with 75 rpm rotating speed, drug release measured by spectroscopic method. Results: From the solubility study, better solubility was seen in Capryol 90(oil), Acrysol K 140(surfactant) and Transcutol P (co-surfactant). Optimized formulation F3 of SMEDDS was observed with smaller droplet size 57.35nm, PDI 0.288 and zeta potential -13.6mV5.Formulation was clear after dilution with water. SMEDDS formulations showed complete release in 60 minutes as compared with pure drug Lurasidone HCl (20mg).which showed a limited dissolution rate. Conclusion: SMEDDS Lurasidone HCl oral formulations were prepared that provides excellent drug solubilization and improved In-Vitro release of Lurasidone HCl.

5

PREPARATION AND EVALUATION OF IN SITU GELLING MICONAZOLE NITRATE LIQUID VAGINAL SUPPOSITORY

Ramandeep Kaur*, Sandeep Kumar, Ghanshyam Das Gupta

A.S.B.A.S.J.S. Memorial College of Pharmacy, Affiliated to I.K Gujral Punjab Technical University, Bela (Ropar), Punjab, India. Pin- 140111.

The key purpose of this study was to prepare and evaluate of in situ gelling Miconazole nitrate liquid vaginal suppository for fungal infection. In situ gelation is a process of gel formulation at the site of application, in which a drug product formulation that exists as a liquid has been transformed into gel upon contact with body fluid or at body temperature. To solve the problem of conventional solid suppositories it would be desirable to develop a liquid suppository which forms a gel at body temperature with suitable gel strength not to be leaked out from vagina after administration and with a suitable bioadhesive force. The liquid vaginal suppository was prepared by cold method using as Poloxamer 407 & 188 as thermo reversible polymer and HPMC, Carbopol 934 and Sodium alginate as mucoadhesive polymer. Liquid suppository was prepared by different combinations of drug and excipients. Formulation was evaluated in terms of pH, Gelation temperature, Gel strength, Mucoadhesive property, Drug content estimation and in vitro drug release etc. Results indicated that HPMC based liquid suppository gave better gelation temperature than others and it was observed that the increased in concentration of HPMC shows decreased in gel strength, mucoadhesive property and drug release of formulation.

6

“A STUDY TO IDENTIFY, ASSESS AND EVALUATE THE INCIDENCE OF INTENTIONAL AND UNINTENTIONAL ORGANOPHOSPHOROUS POISONING IN A SOUTH INDIAN TERTIARY CARE TEACHING HOSPITAL AT DAVANGERE, KARNATAKA”

Pious Mary Ann, T.J. Aparna, T.S. Reshma, Sam Shency, Sam .K. Gloria*.

Department of Pharmacy Practice, Bapuji Pharmacy College, Davangere, Karnataka, India.

Poison is an object of aversion and abhorrence. The prospective observational open labelled study was enrapted to identify, evaluate and assess the incidences of intentional and unintentional organophosphorous poisoning and to assess the relation between demographic factors and organophosphorous poisoning. At the initial phase we identified the type of organophosphorous poisoning then, as per the criteria, we designed a data collection form with specified inclusion and exclusion criteria. We also identified the relation between the demographic factors and poisoning. A total number of 100 cases were collected. Based on our analysis cypermethrin+chlorpyriphos 23% (n=23) was the most commonly consumed organophosphorous compound. On age wise 20-29 years were more prone for poisoning 24% (n=24). Males outnumbered 66% (n=66) females 34% (n=34). Based on economic study low socio economic peoples 50% (n=50) were more prone to poisoning. People from rural area 90% (n=90) accounted for more poisoning cases. Incidence of poisoning were more in married subjects 57% (n=57). On occupational basis students 31% (n=31) were more prone for poisoning. Most of the cases 89% (n=89) were suicidal in nature. Most of the poisoning cases were seen among students. This study describes the importance of patient counselling and essentiality of poison information center in hospitals. Our study also emphasize that both PIC and patient counselling are the most important vital sectors to be concentrated by the clinical pharmacists.

7

CORRELATION BETWEEN SERUM ZINC, INSULIN AND C-PEPTIDE IN PATIENTS OF TYPE 2 DM IN A TERTIARY HOSPITAL IN NORTH INDIA

Obaid M*1, Agrawal BK2

1Department of Biochemistry, Government Medical College, Srinagar, J&K, India.

2Department of General Medicine, MMIMSR, Mullana, Ambala, Haryana, India.

Zinc has been reported to be involved in the synthesis and release of insulin and C-peptide from the beta cells of pancreas. The possibility of a correlation between these parameters needs to be explored, specially with regards diabetes mellitus. We aimed at analysing this relationship in the Indian population by measuring the serum levels of Insulin, C-peptide and zinc in type 2 diabetics. A cross sectional study was undertaken on hundred type 2 diabetic patients in a tertiary hospital (MMIMSR) in North India. Serum C-peptide, insulin were measured by chemiluminescence immunoassay and zinc by spectrophotometry. We found that serum C-peptide and insulin levels were raised (2.59 ± 1.45 ng/ml , 11.24 ± 10.57 ?IU/ml respectively) while serum zinc levels were within reference intervals (97.82 ± 11.27 ?g/dl). Zinc levels however showed highly significant negative correlations with serum C-peptide (r=0.649, p<0.001) and insulin (r= -0.423, p< 0.001) levels. We conclude that serum zinc levels are strongly relate to serum insulin and c-peptide levels in patients of type 2 DM and may thus have a role in the pathogenesis and hence treatment of the disease.

8

PREPARATION AND EVALUATION OF ANTI HYPERTENSIVE IR GRANULES AND ANTI DIABETIC SR MINI TABLETS FILLED CAPSULE SYSTEMS

Dr. M. SUNITHA REDDY*, GUDUGUNTLA SRILATHA, S. MUHAMMAD FAZAL UL HAQ

CPS, IST, JNTUH.

The objective of the present study is to formulate and evaluate the Capsule system with the anti diabetic mini tablets of Glipizide and antihypertensive granules of Losartan potassium with different release patterns by using suitable Excipients. Ethyl cellulose is used as a release retarding polymer in various concentrations in the formulation of the Glipizide mini tablets and the Losartan potassium granules were prepared by using Crospovidone as a super Disintegrant in various concentrations for the immediate drug release. The drug Excipient compatibility studies were performed by FTIR spectroscopy. The pre formulation studies were performed. The in vitro drug release studies were carried out by using the dissolution Apparatus - II at 100rpm in 0.1N HCl for Losartan potassium and 50rpm in 6.8 pH phosphate buffer for Glipizide as described in USP. The simultaneous estimation of both the drugs was carried out by using ultra violet spectroscopy. Optimized formulations are filled in to the hard gelatin capsule systems by using the working formula mentioned above. Formulation CF2 and CF3 showed the best results for the losartan potassium IR (immediate releasing) granules and Glipizide SR (sustained releasing) mini tablets simultaneously. Stability studies were performed for optimized formulation. The capsule systems were observed for accelerated stability studies for a period of two months the obtained results were within specifications.

9

IDENTIFICATION, ASSESSMENT AND ANALYSIS OF SUSPECTED ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL AT SSIMS & RC, DAVANGERE

Theresa Anu, J Anusree, Jacob Merin, Londhe P Sushilkumar

Department of Pharmacy Practice, Bapuji Pharmacy College, Davangere, Karnataka, India.

Adverse drug reactions constitute for about 5% of all hospital admissions in India. And it has become one of the leading causes of mortality and morbidity. Due to the use of newer drugs and different prescribing habits the patterns of ADRs may vary in different hospitals. The objective of the study was to identify, assess and analyze the causative drugs associated with various adverse drug reactions and to report clinical patterns of adverse drug reactions in patients to Adverse Drug Reaction Monitoring Centre at SSIMS & RC, Davangere. The prospective observational study was conducted for a period of 6 months. A strict confidentiality was maintained about the patients details. The data was collected from the identified patient’s case sheets. The prescriptions given to the patient was noted on the data collection form. Of the total of 61 reactions reported the most commonly implicated organ system were skin (63.93%). There were 30 males and 31 females. The major causative drug class was antimicrobials (42.62%). More than half of the reactions were classified as probable (67.21%) according to Naranjo’s scale. In this study a total of 30 (49.18%) patients were recovered and 22 (36.07%) patients were recovering during the time of last assessment. In majority of the ADRs reported, the offending drugs were withdrawn (68.85%) and symptomatic treatment was given (70.49%). In our study most of the ADRs were definitely preventable (59.02%). Our study was conducted to improve public health and patient safety by increasing the risk awareness among health care professionals.

10

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF VILDAGLIPTIN IN BULK AND ITS DOSAGE FORM USING UV SPECTROPHOTOMETER

P. V. Prasad*, K. Divya, M.V. Ramana, A. Krishnaveni, J. Vinay, M. Mahadeswar

SVU College of Pharmaceutical Sciences, Sri Venkateswara University, Tirupati – 517502, Andhra Pradesh, India.

A simple, rapid, precise and economical Analytical method development has been developed for quantitative vildagliptin in manufactured tablet formulation. The stock solution and subsequent dilution of vildagliptin was done in 0.1% NaOH. Solution of vildagliptin in 0.1% NaOH showed absorption maxima at 216.00 nm. The drug obeyed Beers-Lamberts Law in the concentration range of 10-100 ?g/mL with Coefficient of correlation (R2) was 0.997. The standard the method can be adopted in routine analysis of vildagliptin in bulk and tablet dosage form.

11

POTENTIAL ANTITUBERCULAR AND SAR STUDY OF SUBSTITUTED [2-(1-BENZOFURAN-2-YL) QUINOLIN-4-YL] METHANOL AND [2-(1-FURAN-2-YL) QUINOLIN-4-YL] METHANOL ANALOGUES

N. D. Satyanarayan*, Anantacharya R.

Department of Pharmaceutical Chemistry, Kuvempu University, Post Graduate Centre, Kadur-577548, Chikkamagaluru Dt., Karnataka St. India.

ndicating the importance of coupled heterocycles and their important role in the multitude progress of the diseases. In view of this, a series of [2-(1-benzofuran-2-yl) quinolin-4-yl] methanol and [2-(1-furan-2-yl) quinolin-4-yl] methanol (4a-c, 5a-c and 10a-f) were evaluated for their antitubercular activity against H37Rv strain by microplate alamar blue assay (MABA) method. The results revealed that compounds 4a and 5b-c exhibited excellent antitubercular potential at concentration of 1.6 ?g/ml. The compounds 4b-c and 10a-c exhibited good activity at 6.25 ?g/ml and compounds 5a, 10d and 10f showed significant activity at 12.5 ?g/ml when compared with standard drugs pyrazinamide, streptomycin and ciprofloxacin. Furan and benzofuran coupled quinoline moieties are essential for activity as they possess excellent drug like characteristics, suggesting to be potentially best inhibitor of H37Rv strain.

12

A LC-MS/MS METHOD FOR THE QUANTIFICATION OF CLAVULANATE IN HUMAN PLASMA BY NEGATIVE ION MODE AND ITS PHARMACOKINETIC APPLICATION

V.Satish Ramanatham*1,2, P.Venkateswarlu3

*1Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, Telangana State, India.

2Anacipher Clinical Research Organization, Ramanthapur, Hyderabad.

3Vimta Labs Limited, Cherlapally, Hyderabad-500 051, India.

A high performance liquid chromatography tandem mass spectrometric simple protein precipitation method for the estimation of Clavulanate potassium (CLV), in human plasma in Negative ion mode was developed and validated by using Sulbactam (SLB) as internal standard (IS). Sample preparation was accomplished by using 250 ?L of human plasma. The reconstituted samples were chromatographed on Zorbax Eclipse XDB C18 150x4.6 mm, 5?m column using a mobile phase consisting of HPLC grade acetonitrile: 5mM ammonium acetate (70:30, v/v). The flow rate was 1.0 mL/min.The method was validated over a concentration range of 25.220 to 8095.123ng/mL. The validation provides the results of selectivity, sensitivity, matrix effect, calibration standards and quality control samples data, precision and accuracy data, recovery, various stabilities, run size evaluation and dilution integrity. Totally five precision and accuracy batches were performed during the entire validation and intra-day and inter-day precision and accuracy were proved. Concomitant drug effect investigated results are within their limits, not compromised with potentially interfering concomitant medication. The method was validated and was suitable for the quantitation of clavulanate from plasma samples in a pharmacokinetic study.

13

COMPARATIVE INVESTIGATION OF ANTIDIABETIC ACTIVITY OF ACARBOSE, MIGLITOL AND SALACIA OBOLNGA IN PATIENTS OF TYPE 2 DIABETES MELLITUS

Amol D. Landge*, Chaitali. R. Pawar2, Vishal S Lad1, Vijay. M. Sastry1, Prakash. R. Gade3

Gangamai College of Pharmacy Nagaon, Dhule 424001 (Maharashtra).

Government Polytechnic Jalgaon 425001 (Maharashtra). Maharashtra Institute of Medical Sciences and Research Latur 413 531 (Maharashtra).

Acarbose, Miglitol and Voglibose are the marketed ?-glucosidase inhibitor used to reduce post prandial glucose level in the patients of type 2 diabetes mellitus. Increased post prandial blood is cause of number of disease in such patients. Salacia Oblonga and Salacia Reticulata are plants native to India and Sri Lanka these are widely used for thousands of years in Ayurvedic medicine for the oral treatment of diabetes, Attenuation of postprandial glycemia is hypothesized to reduce the risk of progression from impaired glucose tolerance to diabetes. It is also thought to reduce the number of complications associated with diabetes. A clinical trial conducted to assess the comparison of outcome of marketed drugs and with salacia oblonga, found significant effect on weight and HbA1C value of patients of Type II DM.

14

HYPROMELLOSE AND CARBOMER INDUCE BIOADHESION OF ACYCLOVIR TABLET TO VAGINAL MUCOSA

Nilesh M. Mahajan*, Ankit Pardeshi, Debarshi Kar Mahapatra, Arti J. Darode, Nitin G. Dumore

Department of Pharmaceutics, Dadasaheb Balpande College of Pharmacy, Nagpur 440037, Maharashtra, India.

The present research indicates fabrication of an “economic” controlled release bioadhesive vaginal tablets containing acyclovir using only two polymers; Carbopol 934P (as bioadhesive agent) and HPMC K15 (as rate retardant) to provide therapeutic effectiveness for 12 hr duration. The tablets were prepared by direct compression method. The tablets and their constituent materials were evaluated in terms of micromeritics, pharmacopoeial test, and manufacturing parameters. The release mechanism(s) were also elucidated based on various kinetic models. The characteristics were found to be following: average weight of tablets (355-364 mg); drug content (98.91-101.32%); thickness of the tablets (3.21–3.25 mm); surface pH of the tablet formulation (4.41-4.65), hardness of the tablets (5-6 Kg/cm2) and the friability of the batches was less than 1%. Formulation F7 expressed the higher swelling index owing to the higher concentration of HPMC K15 and carbapol 934P. The drug transport mechanism(s) followed non-Fickian diffusion which coincides with swelling erosion mechanism. The drug release process was observed to be governed by two processes; diffusion as well as erosion (often represented as anomalous diffusion). The current study indicated that the hydrophilic matrix tablet of acyclovir, formulated employing only hypromellose and carbomer can successfully be employed as twice daily, very economic bioadhesive vaginal controlled release dosage form. The formulation was found to be suitable with respect to bioadhesive and sustained release characteristic.

15

SOLUBILITY ENHANCEMENT TECHNIQUES SOLUTIONS TO SOLUBILITY PROBLEM

Shaikh Siraj Nawaj*, Saleem Mau Patel, G. J. Khan, Patel M Siddik

Department of Pharmaceutics, Ali-Allana College of Pharmacy Akkalkuwa, Nandurbar, Maharashtra, India.

Ali-Allana College of pharmacy Akkalkuwa Dist, Nandurbar, Maharashtra, India.

Almost 40% of the new chemical entities at present self find out poorly water soluble drugs. Badly water soluble drugs have solubility and dissolution related bioavailability problems. Solubility is one of the most important parameter to give desired concentration of drug in systemic circulation to get its pharmacological response.Orally administered drugs obtained completely absorb only when they show fair solubility in gastric medium and such drugs shows good bioavailability. The solubility and dissolution properties of drugs perform an valuable role in the process of formulation development. Enhancement of solubility of drug is the most challenging job in drug development process. Solubilization may be affected by co solvent water interaction, micellar solubilization, reduction in particle size, inclusion complexes, solid dispersion, and change in polymorph. This review highlighted various techniques of solubility enhancement methods such as Pharmaceutical particle technologies, Milling, Spherical crystallization, drug drug solid dispersion, micro emulsion, self-emulsifying, drug delivery system and supercritical fluid technology.

16

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF VALSARTAN AND SACUBITRIL IN TABLET DOSAGE FORM

M.Madan Mohan Reddy1*, D.Gowri Sankar2, JVLN Seshagiri Rao2

1Eisai Pharmaceuticals India Pvt.Ltd, Ramky Pharma City(SEZ), Parawada, Visakhapatnam, Andhra Pradesh, India-531019.

2College of Pharmaceutical Sciences, Visakhapatnam, Andhra University, Andhra Pradesh, India- 530003.

Objective: A New method was established for simultaneous estimation of Sacubitril And Valsartan by RP-HPLC method. Methods: Chromatographic separations were carried using Spurcil C18 (4.6 x 250mm, 5?m) (Dikma column) column with a mobile phase composition of 0.1% OPA buffer and Acetonitrile(50:50) have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 with PDA detector at wavelength 237 nm. Results: The retention time for Sacubitril and Valsartan were 3.119 and 6.851 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 12-60 ?g/ml for Sacubitril and 13-65?g/ml for Valsartan respectively. For accuracy the total recovery was found to be 99.98% and 100.28% for Sacubitril and Valsartan. The LOD and LOQ concentration for Sacubitril were found to be 0.02 ?g/ml and 0.05 ?g/ml and LOD and LOQ for Valsartan were found to be 0.01?g/ml and 0.04 ?g/ml. The force degradation studies were performed and the results are within the limits. Conclusion: The results of study showed that the proposed RP?HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Sacubitril and Valsartan in pharmaceutical dosage form.

17

TOP DANGEROUS DRUG INTERACTIONS IN LONG TERM CARE AND THEIR MECHANISM, PREVENTION, MANAGEMENT

Dr.Gummalla Pitchaiah*1, Dr. D. Dachinamoorthi2, Dr. SK. Firoz1, Dr. Gaddam Chandrika1, Dr. M. Jyosthna Sri1, Dr. Nalluri Kranthi Koushik1

1Department of Pharmacy Practice, QIS College of Pharmacy, Vengamukkapalem, Ongole, India- 523 272.

2Department of Pharmaceutics, QIS College of Pharmacy, Vengamukkapalem, Ongole, India- 523 272.

Despite a general awareness of the problem of drug interactions and widespread efforts to monitor them, the physician fraternity has failed so far in predicting and preventing them. Because drug interactions could not be generally predicted, one had to wait till they appeared in literature. Drug interactions are complex and chiefly unpredictable as a known interaction may not occur in every individual taking the drug or even a drug in the same class. Most of the drug interactions occur on long term use of drugs and are difficult to predict. This article highlighted the dangerous drug interactions occur on long term care, their impact, mechanism, management and prevention. Understanding these potential reactions and their mechanisms help us to navigate the hazardous waters of combining drugs on long term care.

18

EVALUATION OF IN VIVO NEUROPROTECTIVE EFFECT OF ROOT OF CLITORIA TERNATIA AGAINST ETHIDIUM BROMIDE INDUCED DEMYELINATION RAT MODEL.

G. Neelamma1*, B. Duraiswamy1, Nehru Sai Suresh1, Ch. Vadivelan2, R. Sandhya2, Ch. Justin2

1Department of Pharmacognosy and Phytopharmacy, JSS College of Pharmacy, Ooty, Tamilnadu.

2Department of Pharmacology, JSS College of Pharmacy, Ooty, Tamilnadu.

Clitoria ternatea root is widely used in neuralgia for traditional and herbal medicine. In this study we evaluate the therapeutic strategies to accelerate the reconstruction of lost myelin sheath. The Methanolic root extract of Clitoria ternatea was tested at 100mg/kg and 200mg/kg when administered orally for a period of 28 days after induction demyelination in wistar rats by giving intra cranial injection of ethidium bromide at a dose of 1?g/0.03ml of PBS/kg body weight. The efficacy was expressed in terms of behavioural studies were observed on 1st, 2nd and 4th week. After 28 days the animals were sacrificed and brain tissue was subjected to histopathological and biochemical studies. The result from behavioural, histopathological and biochemical studies suggested that the Methanolic extract of Clitoria ternatea root have potential protective effect on the ethidium bromide induced demyelination on wistar rats by intra cranial administration. In the pharmacological evaluation of methanolic extract of Clitoria ternatea root for their protective effect on demyelinated motor neuron diseases.

19

‘‘A STUDY TO ASSESS THE UTILIZATION PATTERN OF ANTIBIOTICS FOR THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTION IN THE PEDIATRIC DEPARTMENT OF A TERTIARY CARE TEACHING HOSPITAL’’

Mathew Rose Anie, Joseph Mary Navitha, Johnson Seena, J.Muneerudeen.*

Department of Pharmacy Practice, Bapuji Pharmacy College, Davangere, Karnataka, India.

Drug utilization research was defined by WHO in 1977 as the "marketing, distribution, prescription and the use of drugs in the society with special emphasis on the resulting medical, social and economic consequences". Drug utilization plays a significant role in helping the health-care system to understand, interpret and improve the prescribing administration and use of medications. Drug utilization research provides insight to different aspects of drug use and drug prescribing such as pattern of use, quality of use and outcomes of drug use. The objective of this study is to assess the prescribing and utilization pattern of antibiotics prescribed to the patients with LRTI admitted in Pediatric Department. A Prospective observational study was conducted for a period of 6 months. Ethical clearance was obtained from the Institutional Ethical Committee of Bapuji Pharmacy College, Davangere. Data of pediatric patients collected from the Pediatric ward were included in the study. The collected data was analyzed using Microsoft excel. The DDD/1000 inhabitants/day was also calculated. The medication order problem like possible drug-drug interaction is also evaluated. In our study a total of 150 patients were enrolled. Out of the 150 cases, 88patients (58.67%) were males and 62 patients (41.33%) were females. Pneumonia cases (97) were found to be more when compared to all other forms of LRTI.The most commonly found associated illness was anaemia.The average number of antibiotics per prescription was 1.23 and the average hospital stay was 5.7±2.3 days. The mostly prescribed antibiotic was Amoxicillin followed by Ceftriaxone. Most of the drugs were prescribed through parenteral route. That is, 96.22% of the drugs were prescribed through parenteral route and 3.78% were prescribed through oral route. Out of the 150 cases only 14 cases were subjected for performing culture sensitivity test. In our study, a total of 38 interactions were found. In that 4 major, 9 moderate and 25 minor interactions were found. The PDD and DDD of the antibiotics were also compared. Drug utilization studies have the potential to make objective evaluation and analysis of health professionals work and provide them with feedback to stimulate thinking about their practice and looking for ways to improve their own performance. These studies should become a method of increasing job satisfaction and means of education for health professionals, rather than being perceived as threat or another bureaucratic burden.

20

SOLUBILITY ENHANCEMENT OF DIACEREIN BY SOLID DISPERSION TECHNIQUES

Devidas Gulabrao Bachhav*1, Somashekhar S.Khadabadi2

1M.G.V.’s S.P.H.College of Pharmacy, Malegaon, Nashik (MS), India.

2Government College of Pharmacy, Amravati, (MS), India.

The aim of the present study was solubility and dissolution rate enhancement of diacerein by using different solid dispersion techniques. Solid dispersion of diacerein was prepared by kneading and solvent evaporation method. Solid dispersions of diacerein with PEG-6000, guar gum and poloxamer-188 were prepared in different ratios as 1:1, 1:2, 1:3. FTIR, DSC and XRD were performed to study the interaction between drug and polymers. In solid dispersion formulations there was decrease in crystallinity of diacerein, which leads to increase in dissolution of diacerein from solid dispersions. All methods showed improvement in dissolution profile of diacerein as compare to pure drug. Kneading method shows faster drug release as compared to physical mixture and solvent evaporation method (diacerein and poloxamer -188) this might be due to kneading results in uniform distribution of drug in the polymer and forms the molecular and colloidal dispersion of drug in hydrophilic carrier and reduction of crystallinity of drug. As hydrophilic carrier dissolves, an insoluble drug is exposed to dissolution medium in the form of very fine particles, leading to rapid dissolution. Moreover other factors such as absence of aggregation and/or reagglomeration phenomenon during dissolution and particle size reduction could be attributed to a better dissolution profile.

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‘‘PHARMACOECONOMIC EVALUATION ON COST EFFECTIVE ANALYSIS OF ORAL HYPOGLYCAEMIC AGENTS IN A SOUTH INDIAN TERTIARY CARE TEACHING HOSPITAL”

Thampi Anna Ammu, Vijayan Chippy, Ansel Dona, Shibu Sara Shilpa, Sushilkumar.P. Londhe*

Department of Pharmacy Practice, Bapuji Pharmacy College, Davangere, Karnataka, India.

Diabetes Mellitus is "A metabolic disorder characterized by hyperglycaemia resulting from defects in insulin secretion or insulin action or both". "Pharmacoeconomic analysis compares two or more medication options or strategies in terms of their cost and outcome or benefit".The objective of the study is to assess cost effective analysis of oral hypoglycaemic agents on the therapy of patients suffering from Type 2 DM[diabetes mellitus].A prospective observational study was conducted for a period of 6 months in the general medicine OPD[outpatient department] of SSIMS & RC[shammanur shivashankarappa instituteof medical science and research center]. Out-patients who were diagnosed with type 2 diabetes mellitus and receiving treatment specifically with oral hypoglycaemic agents were included in the study. After obtaining the approval from institutional ethical committee, a structured data collection form was developed to collect demographic datas, complete prescription details and other informations required in the study. Among all oral hypoglycaemic agents the most effective drug/combination in the region was identified.A total of 100 case records were identified and assessed in which 59% were males and 41% were females. Maximum number of patients with type 2 DM were from age group of 50-59 years followed by the age group of 40-49 years and then from 60-69 years.Metformin showed a highest difference in the FBS[fasting blood sugar] value of 4.30 mg/dl, while in combinational therapy Metformin + Glimepiride showed a highest difference in the FBS value of 5.94 mg/dl.In single anti-diabetic therapy, Glibenclamide showed a highest cost difference with 1233.2%, in combinational therapy Metformin + Glimepiride showed a maximum cost difference of 194.18%.Analysis of prescription data found that the single most commonly prescribed drug was Metformin and the most common combination used was Metformin + Glimepiride. Metformin alone and Metformin + Glimepiride showed maximum efficacy in control of glucose level. Glibenclamide alone and Metformin + Glimepiride showed most cost effectiveness.

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BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NIRAPARIB IN PLASMA SAMPLES BY LC-MS/MS

Vamseekrishna Gorijavolu*1,2, Ajay Kumar Gupta1, Y.A.Chowdary2 , Raviteja .B3

1Institute of Pharmacy, C.S.J.M University, Kanpur,uttar pradesh , India.

2NRI College of Pharmacy, pothavarappadu, Andhrapradesh, India.

3M.A.M College of Pharmacy, Narasarao pet, Andhrapradesh, India.

In this manuscript, authors developed a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was used for quantification of Niraparib in plasma samples. Zorbax SB-C18, 4.6 x 75 mm, 3.5 ?m, 80 Å column, 5mM ammonium acetate: methanol (30:70 v/v) mobile phase was used for Chromatographic separation of Niraparib. MRM positive mode was used to detect the Niraparib at 321.5?195.4. Liquid-liquid extraction was employed in the extraction of analytes from human plasma. This method is validated over a linear concentration range of 10.0 – 10000.0 pg/mL with a correlation coefficient (r) of ? 0.9997. The developed method was validated and found to be table in plasma samples.