JOURNAL OF DRUG DELIVERY AND THERAPEUTICS

1-7

Authors: Rishi Ram Parajuli, Saroj Shrestha, Shreekrishna Lamichane, Priyanka Pokhrel

The article gives an introduction and general overview on process validation of pharmaceutical tablet manufacturing process. Process Validation is one of the important steps in achieving and maintaining the quality of final product. Process validation emphasizes the role of statistical tools and analyses, knowledge, detection, and control of variability and thus gives assurance on consistency of quality product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the established and documented test methods employed by the manufacturer. Thus, validation is an essential part of the quality assurance. This review examines the need for pharmaceutical validation, the various approaches, process and steps to be monitored during tablet manufacturing process. Key words: Process Validation, Types, Validation Stages, Guidelines and Process.

14-17

Authors: Sanchit Srivastav, Kanishk Luhach, Chhama Shukla, Rajender Yadav

Pyrimidine constitutes an important class of heterocycles in drug discovery & is very well known for their anticancer, antimicrobial, antioxidant & antiviral activities. Hydrazones is a class of organic compounds with the structure R1R2C=NNH2. They are formed usually by the action of hydrazine on ketones or aldehydes & have efficient CNS depressant, analgesics activity. In the same context, Schiff bases of pyrimidine hydrazones can be prepared by the reaction of “4-(4-Chloro-phenyl)-6-methyl-2-oxo-1,2,3,4-tetrahydro-pyrimidine-5-carboxylic acid hydrazide” with various terpenes such as citral, camphor, furfuraldehyde & menthone to make Schiff bases individually by refluxing them in the presence of glacial acetic acid (as solvent) for at least 2hrs to yield their respective derivatives. The present studies revealed that Pyrimidine hydrazone derivatives could be used to synthesize the compounds having potent biological activities such as anticancer, antimicrobial, antioxidant, CNS depressant, analgesic & antiviral activities. All the prepared derivatives were under investigation for their antimicrobial activity and likely to possess the same & desired action. Keyword: Pyrimidine Hydrazones, Biological active Pyrimidine, Schiff Bases etc.

23-30

Authors: Eima Fatima, Arifa Anwar, Mridu Dudeja, Mohd. Akhtar, Abul Kalam Najmi

Background: Urinary tract infection is a key public health issue causing morbidity, especially in women population. This problem is further aggravated in pregnant women. Aims:This study was designed to evaluate the drug prescribing behaviour and adverse drug reaction monitoring in urinary tract infection patients in a tertiary care hospital. Materials and Methods:The present study was prospective, observational and carried out for four months, and done to assess the drug utilization pattern, adverse drug reactions (ADRs) and to identify the bacterial pathogens associated with UTI and their susceptibility to antibiotics.Results:A total of 327 female patients were evaluated, out of which 248 (75.84%) cases were symptomatic. The study reflected maximum of 50.46% UTI in the age group 21-30 years. Pathogens isolated after a urine culture were of both Gram positive 131 (40.07%) and Gram negative 196 (59.93%) type. The maximum incidence (45.80 %) occurred in last trimester of pregnancy. The most frequently prescribed antibiotic to the pregnant patients in our study was Nitrofurantoin, whereas Amoxicillin with Clavulanic acid was most frequently used in non pregnant cases. Most common ADRs reported with almost all classes of antibiotics was nausea and vomiting followed by vaginal irritation, skin rash and photosensitivity.Conclusion:To ensure appropriate therapy, current knowledge of the pathogenic organism and their antibiotic susceptibility pattern is mandatory, especially in cases of UTI with pregnancy. Keywords: Drug utilization pattern,Adverse Drug Reactions, Urinary Tract Infection, Renal Pharmacology

35-42

Authors: R S Kalkotwar, M B Salve, T K Ahire

Objective:- Moist heat sterilization is the most important in pharmaceutical Parentral manufacturing unit. Sterile products have several unique dosage form properties, such as freedom from microorganisms, freedom from pyrogens, freedom from particulates, and extremely high standards of purity and quality; however, the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination. An attempt has been made in this research work to validate the Moist Heat Steriliser with technical parameters classified as Critical and Variable Parameters. Method:- Moist Heat Sterilization method is used for Sterilization of Accessories,Garments ,Silicon tubes, filtration assembly etc. on basis of coagulation of cell proteins. Moist Heat Steriliser is validated every half year to ensure the system is liable to consistently, provide dehydrogenated or sterile product and meets the quality standards. Validation is done by proper planning by taking regular load and experimental load of regular batches of the product. The study is done on Heat distribution, Heat penetration, and Bio burden determination, Minimize the utility cost, and Man hours during sterilization cycle. Result:- The result found in this research work leads to setting up New approach to Validate Moist Heat Steriliser in Parentral manufacturing unit with cost effective way. Conclusion:- The Path finder validation process setup through this project is Cost saving through Energy as well as Man Hour Saving and Breakage of Units also maintain Sterility in product. It is helpful to find out Hot and Cold Spots in Moist Heat sterilizer and Designing and Placement of RTDs. The findings were submitted to the Parentral Department of Vital HealthCare Pvt. Ltd., Satpur. MIDC, Nashik. KEYWORDS:-Moist heat Sterilization , Process Validation , Critical and Variable parameters.

56-59

Authors: Dr G Sasikala

Aim & Objective: This study was designed to evaluate the metabolic effects of risperidone in patients with psychiatric illness treated with risperidone. Method: Thirty non-diabetic patients with Psychiatric illness (e.g. schizophrenia, manic phase of bipolor disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) inducted in this study. These Patients did not receive any drug that would alter the blood sugar levels and also risperidone for at least four weeks prior to the initiation of the study. All the patients who were inducted in this study receive the mean dose of 4mg/day (range 2-8 mg) of risperidone for eight weeks, depending upon the clinical condition. The patients fasting, post prandial blood sugar and weight gain were evaluated at the baseline and then at four weeks and at eight weeks. Results: Thirty patients completed the study. The mean fasting blood sugar level was increased from 87.5mg/dL (baseline) to 101.7 mg/dL at week 8 (P<0.001).The mean post prandial blood sugar was increased from111.68 mg/dl to147.88 mg/dl at week 8 (p<0.001).There was also statistically significant weight gain with a increase in mean weight of59.16 kg to59.96 kg (p=0.001). The 8-week study showed that fasting blood sugar and postprandial blood sugar levels may increase in psychiatric patients receiving risperidone .There was also definite weight gain. No serious adverse events were reported. Conclusion: Measuring and monitoring fasting & postprandial blood sugar before the initiation and during the treatment with risperidone is suggested. Key Words: Metabolic effect, Risperidone , Blood glucose, psychiatric illness.

63-67

Authors: M Naveen, K G Siddalingeshwara

Recently, xylanases have expanded their use in many processing industries, such as pulp and paper, food and textile to newer needs such as biofuel production. .This study were taken up to the enhance the biosynthesis of xylanase by supplementation of carbon sources were employed in range of 0.25% to 1.0%. The carbon source were supplemented are glucose, sucrose and maltose. The beef extract and ammonium nitrate were yielded higher xylnase production and showed 7.5 IU and 8.4 IU. Key words: Xylanase, submerged fermentation, xylose, fermentation kinetics and inoculums size.