IAJPR

Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
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AUGUST 2018
1

INVESTIGATION OF IN VITRO ANTHELMINTIC ACTIVITY OF BARK OF EMBLICA OFFISNALIS

Matsyagiri. L*, Prapulla. P, Dr Hemamalini. K
*Swami Vivekananda Institute of Pharmaceutical Sciences, Vangapally, Yadagirigutta, Yadadri- Bhuvanagiri-508286, Telangana, India.

The aim of the present study was investigation of in vitro antihelmentic activity of crude methanolic and aqueous extract of bark of Emblica officinalis using Pheretima posthuma as test worm. Various concentrations of (25, 50, 100 mg/ml) of methanolic and aqueous extracts were tested in the bioassay, which involved the determination of time of paralysis (P) and time of death (D) of the worms. Albendazole was included as standard reference and distilled water as control. The both extracts showed greater P and D time when compared with the standard reference Albendazole. The results of present study indicated that the crude aqueous extract significantly paralysis and also caused death of worm in short time, as compared to methanolic extract. In conclusion, the traditional use of stem bark of the plant of Emblica officinalis as an antihelmentic activity have been confirmed and further studies are suggested to isolate the active principles responsible for activity.

2

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR ESTIMATION OF ARGATROBAN IN HUMAN PLASMA BY LC-UV

Varsha Rajkumar Jamakhandi, M S Kalshetti
Department of Quality Assurance, College of Pharmacy, Solapur, Maharashtra, India.

LC-UV method for quantification of Argatroban in human plasma has been developed and validated. Drug is extracted by protein precipitation technique using methanol. Separation has been performed on Phenomenex C8 column (150 × 4.6 mm, 5 ?m) with Phenomenex Security Guard Cartridges C8 (4x3mm) using acetonitrile: methanol: water (33:17:50) as mobile phase at 1.0 ml/min flow rate at 259 nm. The calibration curve was linear over concentration range of 200-5000 ?g/ml (r2=0.999). Argatroban was eluted at 4.2 min. The method is sensitive, precise and accurate. The method can be used for estimation of Argatroban in human plasma.

3

DESIGN AND DEVELOPMENT OF SIMVASTATIN FLOATING TABLETS FOR CONTROLLED RELEASE

N. G. Raghavendra Rao1*, M. Laharika2
1GRD [PG] Institute of Management and Technology, Rajpur, Dehradun – 248009, Uttarakhand, India.
2Graviti Pharmaceutical Private Limited, IDA Pashamylaram, Hyderabad - 502307, Telangana, India.

Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is a Hypolipidemic used to control elevated cholesterol or hypercholesterolemia. The primary uses of Simvastatin are for the treatment of dyslipidemia and the prevention of cardiovascular disease. Floating tablets of Simvastatin were developed by direct compression method to increase the gastric retention time using HPMC K4M, Carbopol and sodium CMC polymers used and the mixture of the sodium bicarbonate, citric acid anhydrous as gas generating agents. The results of Pre-compressional and post-compression parameters were within IP prescribed limits. All the formulations (FB1-FB10) prepared the formulations FB1, FB2 and FB8 fails to float. Among all the formulations batch FB7 was the best formulation which showed buoyancy lag time 2 min and the tablet remained buoyant for 12hrs. The floating capacity increased in these formulations and floated with less lag time due to the high concentration of gas generating agent sodium bicarbonate. DSC and FTIR studies revealed that there was no incompatibility of the drug with the excipients used. The stability study conducted as per the ICH guidelines and the formulations were found to be stable. From this study, it can be concluded that the FB7 was the best formulation retained for longer periods of time in the stomach and provides controlled release of the drug and may improve bioavailability.

4

OPTIMIZATION OF STRESS CONDITIONS OF FORCED DEGRADATION STUDY BY UV SPECTROPHOTOMETER

Mr. A B Roge, Dr. G R Shendarkar*
CRPS, Nanded Pharmacy College, Nanded.

Forced degradation study (FDS) is an emerging trend, requisite to be performed and reported while filing abbreviated new drug application (ANDA) and investigational new drug application (IND) application. Modern analytical instruments like HPLC, UPLC, and LC-MS etc. are commonly used throughout the intact study. These methods are more specific, accurate but also costly and time consuming. Optimization of stress conditions is a critical part of study as standard values are not revealed by regulatory authorities. The objective of this work is to explore role of UV spectrophotometer in FDS and to overcome above problems. In this study, FDS of Gallic acid has been carried out using UV spectrophotometer. Gallic acid was exposed to different stress conditions like acidic and alkaline hydrolysis, oxidation, dry heat and photolytic degradation. UV spectrum of sample subjected to stress conditions was recorded and compared with standard spectrum. It was found that Gallic acid has undergone degradation in acidic (HCl), alkaline (NaOH) and oxidative media (H2O2). However, it was found stable at thermal and photolytic stress conditions. The present study explains usefulness of UV-Visible spectrophotometer in FDS which helps to save time and expenditure required for study.

5

A PROSPECTIVE OBSERVATIONAL STUDY ON NON ALCOHOLIC FATTY LIVER DISEASE

K. Maneesha1, P. Kishore1, Y. Ravalika2, Narasimha Reddy3, D. Sudheer Kumar4, R. Deepthi1*
1,2 Department of Pharmacy Practice, Care College of Pharmacy, Warangal, Telangana.
3PNR GUT& LIVER CLINIC, Hanumakonda, Warangal, Telangana.
4Department of Pharmaceutics, Care College of Pharmacy, Warangal, Telangana.

Nonalcoholic fatty liver disease (NAFLD) is becoming one of the most prominent causes of liver disease worldwide. Though NAFLD is increasingly prevalent in the Indian population, knowledge regarding the burden, risk factors, presentation and etiology of NAFLD is limited. Since last 2 decades there is a higher prevalence of obesity, Type 2 DM, Dyslipidemia, HTN, Insulin Resistance in Indian population with increased likelihood of these risk factors, there is a chance of greater prevalence of NAFLD. This study aims to study clinical profile and associated risk factors in patients with NAFLD. Our study was conducted over a period of 8 months in Department of Gastroenterology in a private clinic of Telangana region. A total of 324 patients diagnosed with NAFLD by ultrasonography were enrolled in the study. Prevalence was seen higher in male than female, more in urban population than rural and higher in 31-50 year age group. Mean age group was 44.20 years. Pain in abdomen was the most common clinical presentation. Risk factors were observed in [67.2%] patients and was more prevalent in 41-60 years age group. The most prevalent risk factor is HTN > Obesity > DM. 87% of patients had Grade1 fatty liver. The study concludes that there is higher prevalence of risk factors in NAFLD patients. Thus there is a need for creating awareness regarding the disease and risk factors in general population for early detection and treatment.

6

MULTICOMPONENT REACTIONS AND RECENT ADVANCES IN THE APPLICATIONS OF OXADIAZOLES FROM 2017-18: A REVIEW

Somashekhar M*, R B Kotnal
Department of Pharmaceutical Chemistry, BLDEA’s SSM College of Pharmacy and Research Centre Vijaypur-586101, Karnataka.

1,3,4-Oxadiazole is a thermally stable and neutral Heteroaromatic molecule having a wide variety of uses, particularly as biologically active compounds in medicine, agriculture, dye stuffs, UV absorbing and fluorescent materials, heat resistant polymers and scintillators. Oxadiazoles and their analogues can be considered as simple five membered heterocycles possessing one oxygen and two nitrogen atoms1-6. The oxadiazole exists in different isomeric forms such as 1,3,4- oxadiazole, 1,2,5-oxadiazole, 1,2,4-oxadiazole, and 1,2,3-oxadiazole, out of which 1,3,4-Oxadiazole is a thermally stable neutral aromatic molecule and its estimated resonance energy is 167.4 kJ/mol. particularly, aryl group at position 2 increases the thermal stability of 1,3,4-oxadiazole. The ring is stable to heat, a property which has been exploited in the production of heat-resistant poly-1,3,4-oxadiazoles. UV spectra of substituted 1,3,4-oxadiazoles are similar to those of substituted benzenes, particularly in the case of 2-phenyl-1,3,4-oxadiazoles7-18 (?max in ethanol = 247.5 nm, log ? 4.26).

7

DEVELOPMENT OF UV SPECTROPHOTOMETRIC ASSAY METHOD FOR DETERMINATION OF IVABRADINE HYDROCHLORIDE IN BULK AND FORMULATED MICROSPHERE DOSAGE FORM

S N Firke, N B Ghiware*, S B Dhoot, A B Roge, V N Gunjkar, A T Sharma
CRPS, Nanded Pharmacy College, Nanded.

Ivabradine is a heart rate lowering agent and controls the spontaneous diastolic depolarization in the sinus node to regulates heart rate. It is soluble in water, hydrochloric acid and in methanol. A simple, sensitive, precise and highly accurate UV spectrophotometric method has been developed for determination of Ivabradine HCL in formulated microsphere dosage form. Ivabradine HCl exhibited ? max at 286 nm in water, 0.1 N HCL solution and obeyed linearity in the concentration range of 20-100 mcg with Coefficient of determination value (R2) of 0.9960 . The slope, intercept, correlation coefficient, detection and quantitation limits were also calculated and found within statistical perimeter. Result of percentage recovery shows the method was not influenced by the presence of impurities or excipients. The method was validated by determining its sensitivity, accuracy and precision which proves suitability of the developed method for the routine estimation of Ivabradine in microsphere dosage form.

8

SYNTHESIS, ANTITUBERCULAR AND ANTIBACTERIAL ACTIVITIES OF NOVEL PYRROLYL BENZOHYDRAZIDE DERIVATIVES

Tabasum Killedar, Sneha Shiraguppi, Sandhya Chinnamulagund, C. S. Hallikeri, Sheshagiri R. Dixit, V. H. Kulkarni, Shrinivas D. Joshi*
Novel Drug Design and Discovery Laboratory, Department of Pharmaceutical Chemistry, S.E.T’s College of Pharmacy, Sangolli Rayanna Nagar, Dharwad 580 002, India.

Novel series of pyrrole derivatives were synthesized with an approach to reduce the growing anti-tubercular resistance and to develop more potent and less side effect anti-tubercular agents. Herein, we synthesized a series of substituted 2-phenoxybenzamide derivatives (3a-j) by reacting different phenoxy acetic acids with 4-(-1H-pyrrol-1-yl)benzoate (2) and a series of pyrrolyl benzamides (6a-c) were synthesized by reacting 4-(1H-pyrrol-1-yl)benzoic acid with different hydrazides 2, (5a-b) using HBTU as a coupling agent, DIEA as a catalyst and DMF as a solvent. Structures of all the newly synthesized compounds were confirmed by spectral analysis viz., IR, 1H NMR, 13C NMR and Mass. Further they were tested for their anti-tubercular and antibacterial activities and compounds showed moderate to good activity.

9

A STUDY ON DETECTING ADVERSE DRUG REACTIONS REPORTING IN A TERTIARY CARE TEACHING HOSPITAL

Purushothama Reddy K1*, Dr. Rajesh Asija2, Dr. M. Purushothaman3, Dr. S. Arshiya Banu4

*1Rao's College of Pharmacy, Nellore, A.P – 524 320.
2Sunrise Pharmacy College, Sunrise University, Alwar, Rajasthan, India.
3Scient Institute of Pharmacy, Ibrahimpatnam, R. R. District – 501 506, Hyderabad, Telangana, India.
4P. Rami Reddy Memorial College of Pharmacy, Kadapa, A.P – 516003.

Background: An adverse drug reaction (ADR) is a reaction which is noxious and unintended and which occurs at dosages normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. It is important to identify the risks for ADRs, hence forth the common drugs causing ADRs, their therapeutic class, demographic data of patients suffered from ADRs & concomitant medications used should be known. Also ADR specific data such as type of reaction, system affected and probable causes will be of great help to minimize the ADRs. To detect the ADRs through spontaneous reporting system in our tertiary care teaching hospital and analyzing them by using World Health Organization (WHO) assessment scales. Method: An prospective observational study was conducted based on ADRs reporting between 1st June 2017 to 31st May 2018 to the ADR reporting unit of the our hospital i.e., Pharmacovigilance cell. The ADRs reported by spontaneous reporting system were from patients attending outpatient department (OPD), inpatient department (IPD) and casualty department. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics and outcome of the reactions. Assessment was also done for causality and severity. Result: Total 2639 ADRs were reported with in the period from 1st June 2017 to 31st May 2018. Antimicrobial agents (AMA) were the drug class most commonly involved and Non-Steroidal Anti-inflammatory Drugs (NSAIDs) were next to AMA. Cotrimoxazole a well-established agent was the individual drug most frequently reported in this study. Upon causality assessment, majority of the reports were rated as probable (55.89 %). Conclusion: The pattern of ADRs reported in our hospital is comparable with the results of other studies conducted in various hospital set up elsewhere. AMAs were causing maximum ADRs. This study provides a database of ADRs due to common drugs used in our hospital, which will help clinicians for optimum and safe use of these drugs. Hence strict vigilance is required for the use of these likely drugs and their safety assessment.

10

ADR ASSESSMENT METHODS: AN OVERVIEW

Purushothama Reddy K1*, Dr. Rajesh Asija2, Dr. M. Purushothaman3, Dr. S. Arshiya Banu4
*1Rao's College of Pharmacy, Nellore, A.P – 524 320.
2Sunrise Pharmacy College, Sunrise University, Alwar, Rajasthan, India.
3Scient Institute of Pharmacy, Ibrahimpatnam, R. R. District – 501 506, Hyderabad, Telangana, India.
4P. Rami Reddy Memorial College of Pharmacy, Kadapa, A.P – 516003.

Adverse drug reaction (ADR) is defined as any response to a drug which is harmful and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. An increased understanding of the prevalence and nature of ADRs, as well as recognition of patients perspectives on quality of life, would enable us as a profession to identify and target specific areas for vigorous pharmaceutical care. It is important to identify the risks for ADRs as they are life threatening, henceforth the common drugs causing ADRs, their therapeutic class, demographic data of patients suffered from ADRs and concomitant medications used should be known. Also, ADR specific data such as type of reaction, system affected and probable causes will be of great help to minimize the ADRs. The process of defining and concluding about ADRs should be continuous and ongoing to keep a record of newly marketed drugs and medicinal products. More over strict drug analyzing, clinical data and in vivo study is also required if feasible. This article focuses on the adverse reaction and its assessment methods.

11

PHARMACOVIGILANCE PROGRAMME IN INDIA PRESENT CIRCUMSTANCE AND ITS PERSPECTIVES

Purushothama Reddy K1*, Dr. Rajesh Asija2, Dr. M. Purushothaman3, Dr. S. Arshiya Banu4
*1Rao's College of Pharmacy, Nellore, A.P – 524 320.
2Sunrise Pharmacy College, Sunrise University, Alwar, Rajasthan, India.
3Scient Institute of Pharmacy, Ibrahimpatnam, R. R. District – 501 506, Hyderabad, Telangana, India.
4Rami Reddy Memorial College of Pharmacy, Kadapa, A.P – 516003.

Adverse drug reaction (ADR) is defined as any response to a drug which is harmful and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. An increased understanding of the prevalence and nature of ADRs, as well as recognition of patients perspectives on quality of life, would enable us as a profession to identify and target specific areas for vigorous pharmaceutical care. It is important to identify the risks for ADRs as they are life threatening, henceforth the common drugs causing ADRs, their therapeutic class, demographic data of patients suffered from ADRs and concomitant medications used should be known. Also, ADR specific data such as type of reaction, system affected and probable causes will be of great help to minimize the ADRs. The process of defining and concluding about ADRs should be continuous and ongoing to keep a record of newly marketed drugs and medicinal products. More over strict drug analyzing, clinical data and in vivo study is also required if feasible. This article focuses on the adverse reaction and its assessment methods.

12

FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE ORAL DISPERSABLE TABLETS

Muggu SankaraBhavani, K.Sudha Rani, K.HarshaVardhan, M.BhavyaSalini
Hindu college of Pharmacy, Amaravathi Road, Guntur, A.P.

Metformin HCL is a biguanide antihyperglycemic agent used for treating non-insulin-dependent diabetes mellitus (NIDDM). It improves glycemic control by decreasing hepatic glucose production, decreasing glucose absorption and increasing insulin mediated glucose uptake. In the present study an attempt has been made to prepare oral dissolving tablets of Metformin HCL which dissolves fast and easy in the oral cavity with enhanced dissolution rate. The tablets were prepared with two superdisintegrants e.g., Croscarmellose sodium, Sodium Starch Glycolate. The blend was examined for Angle of repose, Bulk density, Tapped density, Compressibility index and Hausners ratio. The tablets were evaluated for hardness, friability, disintegration time, dissolution rate, drug content were found to be within 30 sec. It was concluded that the mouth dissolving tablets with proper hardness, rapidly disintegrating with enhanced dissolution can be made using selected superdisintegrants.