ARCHIVES(Journal of Harmonized Research in Pharmacy)


Title: ANTIEPILEPTIC DRUGS: TREATMENT IN ELDERLY PATIENTS.
Author: Callegari C. *, Bianchi L., Vender S
Keyword: Antiepileptic drugs, elderly patients, gabapentin
Page No: 96-102
Abstract: Introduction: This study aims to examine qualitatively the use of AEDs in a population of elderly patients in nursing homes, including the prescription of specialist and monitoring. Methods: This p revalence study was carried out in a state-founded nursing home providing assistance and rehabilitation for elderly people. The first objective of the study is to determine the prevalence of the use of antiepileptic drugs. The second objective is to study the monitoring the dosage modification from the time of admission of the patient until the end of the study. Results: In the period of time that we took into consideration 65 of 402 patient’s monitored patients had at least one anti-epileptic therapy (prevalence of 32%). The antiepileptic drug most prescribed was gabapentin with a frequency of 63.6%. Discussion: The prevalence use of AEDs has beeen 32%. The second objective concerns the drugs monitoring and it has also been achieved and shows how gabapentin is the most prescribed drug (53.8% psychiatrist) and was introduced mainly for anxiety disorders, psychosis, neuropathic pain and mood disorders. Keywords: Antiepileptic drugs, elderly patients, gabapentin Download PDF


Title: INNOVATIVE PEDIATRIC DRUG DELIVERY SYSTEMS
Author: Ankita Mistry and Sonali Kapse-Mistry
Keyword: Pediatric, pharmacokinetics, innovative devices, transdermal, transmucosal, pulmonary, HIV
Page No: 117-130
Abstract: Administration of pediatric medicines needs to be accurate and to ensure the correct dose, the administration device should be easy to use and acceptable. Continuous development and maturation of ped iatric organs involved in drug metabolism and clearance results in pharmacokinetic changes are focused. The review provides an overview of currently available innovative pediatric administration devices and highlights some of the challenges associated. Recent developments in oral transmucosal, parenteral, rectal, pulmonary and transdermal delivery to achieve better systemic drug levels in pediatric population are highlighted. A new nipple shield delivery system to deliver antiretroviral drug formulations to HIV infants to prevent mother-to-child HIV transmission during breastfeeding is discussed as a safe alternative. However the future of pediatric medicine is promising but challenges still remain. Keywords: Pediatric, pharmacokinetics, innovative devices, transdermal, transmucosal, pulmonary, HIV Download PDF


Title: POLOXAMER 188 USED AS WATER SOLUBLE CARRIER FOR ENHANCED DISSOLUTION RATE OF PIROXICAM BY SOLID DISPERSION TECHNIQUE
Author: Atneriya U K*, Gupta M K, Jain Neetesh Kumar
Keyword: Solid Dispersion, Dissolution Rate, Poloxamer 188, Piroxicam, Bioavailability.
Page No: 103-116
Abstract: Piroxicam is a long acting potent Non-Steroidal anti inflammatory drug with inflammatory potency and good analgesic-antipyretic action. It is a reversible inhibitor of COX lowers PG concentration in synovial fluid and inhibits platet aggregation prolonging bleeding time. In addition it decreases to IgM rehumatoid factor and leucocyte chemotaxis. Thus it can inhibit inflammation in diverse ways. It is practically insoluble in water and a biopharmaceutics classification system class II drug and exhibits a slow rate of dissolution in aqueous media, resulting in its poor oral bioavailability. Solid dispersion is widely used to increase the dissolution rate, and hence improving the bioavailability of poorly water soluble drugs. It is still a challenge for the formulation scientists to develop an oral dosage form of Piroxicam having a faster rate of dissolution. The present research work was aimed to develop a fast dissolving oral dosage form of Piroxicam for enhancing its bioavailability. The solid dispersion of Piroxicam was prepared by solvent evaporation technique using Poloxamer 188 as a carrier. The fast dissolving tablet of Piroxicam were developed using Piroxicam-Poloxamer 188 solid dispersion. The developed tablets of solid dispersion exhibited about a 10 fold enhancement in the dissolution rate resulting upto 98% drug release in 1hr. The problem of poor dissolution of Piroxicam could be successfully resolved through solid dispersion technique using Poloxamer 188 as a carrier. Procured drug sample of Piroxicam was characterized by melting point determination XRD and UV spectroscopy. The prepared solid dispersion was characterized using powder XRD techniques. The findings demonstrate that poloxamer 188 can successfully resolve the problem of slow dissolution and poor bioavailability of Piroxicam through solid dispersion approach. Key Words:- Solid Dispersion, Dissolution Rate, Poloxamer 188, Piroxicam, Bioavailability. Download PDF


Title: EVALUATION OF KNOWLEDGE, AWARENESS AND ATTITUDE PRACTICE AMONG PHARMACIST IN PHARMACOVIGILANCE AT TERTIARY CARE HOSPITAL IN DELHI
Author: Sunita Kumari and Palaniappan Senthilkumar
Keyword: Pharmacovigilance; Adverse Drug Reaction; Educational intervention; pharmacists; Tertiary care hospital; KAP.
Page No: 131-139
Abstract: Objective: To study the knowledge of pharmacist and their attitudes for reporting Adverse Drug Reactions and also to find out their participation in reporting Adverse Drug Reactions in Tertiary care hospital in Delhi. Methods: This study was conduct by using validated KAP questionnaire. The reliability of validated KAP questionnaires was analysed by conducting pilot study on 50 Pharmacist and calculating Cronbach Alfa value (0.823), in order to identify the Knowledge, attitude, practice of Pharmacovigilance. Based on the previous study conducted, the sample size (230) was calculated by using SPSS v21.0 with the significance level of P < 0.001.Result: In this study total 230 Pharmacists responded. The overall response rate was significant in pharmacists (P < 0.001).Conclusion: The overall response of pharmacist showed that pharmacist working in industrial as well in hospitals lack awareness about Pharmacovigilance and they need to update their knowledge and practice for drug safety and Pharmacovigilance. There is a regular basis need for an educational intervention to update the knowledge and awareness in their everyday clinical practice. Keywords: Pharmacovigilance; Adverse Drug Reaction; Educational intervention; pharmacists; Tertiary care hospital; KAP. Download PDF


Title: ANTICONVULSANT PROFILE OF COMBINATION OF ANNONA SQUAMOSA, NARDOSTACHYS JATAMANSI AND BACOPA MONNIERI AND EPI CAPS IN MICE
Author: Foram Parikh* and Kedar Prabhavalkar
Keyword: Nardostachys jatamansi, Annona squamosa, Bacopa monnieri, Anti convulsant, Pentylenetetrazole, Maximal Electroshock, Epi caps
Page No: 140-147
Abstract: Several studies have indicated the role of Annona squamosa, Nardostachys jatamansi, Bacopa monnieri for its anti convulsant effects individually. Thus a combination of these extracts along with a mar keted formulation Epi caps was evaluated for its anti convulsant potency. Acute Oral Toxicity was performed as per OECD 423 and this combination was found to be safe upto 2000mg/kg. The combination of extracts was given in 100mg/kg and 200mg/kg for 14 days. The anti convulsant potency of these drugs was evaluated using Pentylenetetrazole and Maximal electroshock models for epilepsy in mice. The results evidently suggest that the combination of extracts as well as Epi caps were able to control the extent and severity of seizures in PTZ and MES models. Keywords: Nardostachys jatamansi, Annona squamosa, Bacopa monnieri, Anti convulsant, Pentylenetetrazole, Maximal Electroshock, Epi caps Download PDF


Title: CHEMICAL FINGERPRINT ANALYSIS, IN-VITRO ANTIMICROBIAL ACTIVITY AND TOXICOLOGICAL ASPECTS OF A POLYHERBO-MINERAL OIL FORMULATION: KUSTHARAKSASA TAILA
Author: Nidhi Dubey *
Keyword: Ayurveda, antibacterial, antidermatophytic
Page No: 148-161
Abstract: The objectives of the study were to test the polyherbo-mineral oil Kustharaksasa taila (KT) for in vitro antimicrobial activity against Gram-negative and positive bacteria, Candida species and dermat ophytes, to evaluate its acute toxicological effects in vivo and to obtain the chemical fingerprints using various analytical techniques.The antimicrobial activity, in vitro, was initially evaluated by the agar-well diffusion technique, and the MIC and minimum fungicidal concentration (MFC) were determined by the broth micro-dilution method. The acute toxicological effects were determined in rabbits and rats, respectively. The chemical fingerprints of the oil were obtained by gas chromatography coupled to mass spectroscopy, High performance thin layer chromatography (HPTLC), Fourier transform infra red (FTIR) spectroscopy and X-Ray powder diffraction (XRPD) analysis.The KT was found effective against all tested strains in agar well diffusion method. The minimum inhibitory concentration of KT ranged from 19.5 to 312 µg/ml, the minimum bactericidal concentration ranged from 39 to 312µg/ml while the minimum fungicidal concentration ranged from 156 to 625 µg/ml. The acute administration and dermal application of KT was devoid of toxicity in rats. The characteristic chromatographic peaks of the chromatographic fingerprints and d spacing values in the XRD spectra were summarized for future qualitative analysis. KT may be a promising source in the search for new antimicrobial drugs due to its efficacy and low toxicity. Key words: Ayurveda, antibacterial, antidermatophytic Download PDF


Title: A REVIEW ON CHROMONES – BIOLOGICALLY ACTIVE PHARMACOPHORES
Author: Anuja Chopra*, ManpreetKaur, Navpreet, Divneet, Lalit
Keyword: Chromones, Anticancer, Antibacterial, Flavone, Antioxidants.
Page No: 162-172
Abstract: ABSTRACT Oxygen containing heterocycles are abundantly found in nature. Flavone, isoflavones, flavanones, catechins, anthocyanins are some phytoconstituents collectively grouped as flavonoids and iso flavonoids. Chemically, they are categorized as chromenes, chromenones, dihydrofurobenzofurans, chromanochromanones, benzofurochromans, xanthones and amphipyrones. Chromones (4H-Benzopyran-4-ones) are the heterocyclic compounds with benzopyron network with substituated keto group on pyron ring. It is an isomer of coumarin. Chromone nucleus is recognised as pharmacophore having a number of biological activities such as anticancer, antiviral, antifungal, antimicrobial, antioxidant, antidepressant, antiobesity. These derivatives also possess enzymetic inhibition properties towards different systems such as oxidoreductase, kinase, lipoxygenase and cycloxygenase. Chromone moiety is obtained from number of sources such as plants, marine and synthetic sources. These are khellin, aloesin, kaemferol, hormothamnione, asperginone and flavopiridol. So, this chromone nucleus find use as valuable synthetic intermediates in the preparation of pharmacologically relevant products and new heterocyclic systems. Keywords: Chromones, Anticancer, Antibacterial, Flavone, Antioxidants. Download PDF


Title: DESIGN AND DEVELOPMENT OF CONVENTIONAL TABLETS OF HYDROCHLOROTHIAZIDE AND PROPRANOLOL HYDROCHLORIDE CO-CRYSTALS
Author: Madhavi U. Bhandwalkar*, Omkar S. Bhandwalkar, Pallavi S. Dhekale, Dhairyasheel M. Ghadge, Ujwala K. Jamdade
Keyword: HCT, PPL, Solvent evaporation, Solution co-crystallization, Characterization.
Page No: 173-180
Abstract: Hydrochlorothiazide (HCT) is a class IV drug which has limited solubility and permeability, for overcome this problems co-crystallization method is used. Co-crystallization is the process to enhance the physical properties of drug molecule especially the solubility. HCT belongs to diuretic category and Propranolol Hydrochloride (PPL) belongs to Beta blocker category they are combined for use in tablet formulation. Co-crystallization was used to combine two drugs in single solid phase and thus to achieve new approach for combination therapy. Using the new approach co-crystals of PPL with HCT were prepared. Co-crystallization of two drugs were carried out by using solvent evaporation and solution co-crystallization method. The saturation solubility was done to evaluate the solubility of co-crystals. Dissolution properties were determined and compared with the marketed tablet formulation. The prepared co-crystals has shown several times faster release than marketed tablet and optimized co-crystals were characterized by using DSC, FTIR and SEM. Keywords: HCT, PPL, Solvent evaporation, Solution co-crystallization, Characterization. Download PDF


Title: QUALITY ASSURANCE ASSESSMENT OF SOME COMMERCIALLY AVAILABLE ERYTHROMYCIN STEARATE TABLETS.
Author: Johnbull Aiwaguore Obarisiagbon*, Oladejo Peter Ogunlowo
Keyword: Stearic acid, formulation, physicochemical, friability
Page No: 181-188
Abstract: Erythromycin drug products have been mostly imported into Nigeria from different countries of the world; with relatively no Nigeria based pharmaceutical company manufacturing same. Cases of therapeut ic failures have been reported in some of our hospitals. Hence, the need arises to study some of the physicochemical parameters of some of the available drug products in the Nigerian Pharmaceutical Market with a view to detecting drug products that meet the specified pharmacopeia standards and those that fall short of such standards. The parameters measured were the uniformity of weight, friability, tensile strength, disintegration time and dissolution rate of 12 selected erythromycin stearate 500mg film-coated tablets. The tensile strength of the tablets was determined using the static loading method and Mosanto hardness tester to find the crushing strength and their results compared. The 12 samples disintegrated within 30mins with four of them disintegrating within 3mins, suggestive of possible inclusion of superdisintegrants in their formulations. All products, except two had a percentage release of the drug within 90mins of 70% and above. The friability of three of the products exceeded 1%. However, their tensile strengths did not prolong the disintegration time beyond the official limits. The results obtained from the physicochemical testing of the drug products revealed the failure of two products having release rates of less than 70% within 90mins. Further tests need to be done on these two products (namely Rycin® and Erythromycin 500mg) in order to draw a more definite conclusion. Keyword: Stearic acid, formulation, physicochemical, friability Download PDF


Title: SIMULTANEOUS ESTIMATION OF DIDANOSINE AND STAVUDINE IN COMBINATION IN SYNTHETIC MIXTURE BY RP-HPLC
Author: Richa. A. Dayaramani*, Paresh U Patel
Keyword: Stavudine, Didanosine, Simultaneous estimation, RP-HPLC, Synthetic mixture.
Page No: 189-200
Abstract: A validated RP-HPLC analytical method has been developed for the simultaneous estimation of Didanosine and Stavudine in bulk and in a synthetic mixture prepared in the laboratory. The proposed method is fast, simple, accurate, precise, specific, and has ability to separate drug from excipients if found in formulation if developed in future. The method is suitable for routine simultaneous analysis of Didanosine and Stavudine. The method can be successfully applied in simultaneous analyses of the two drugs in case of extensive clinical trials. The simplicity of the method allows for application in laboratories that lack sophisticated analytical instruments such as LC–MS. The proposed method requires no sample pre treatment and is quite economical for routine analyses. Key Words: Stavudine, Didanosine, Simultaneous estimation, RP-HPLC, Synthetic mixture. Download PDF


Title: EXPLORING PHARMACOVIGILANCE: A NARRATIVE REVIEW
Author: Bhumeshwar Sharma, Sourabh Kosey, Neelesh Kumar Mehra, Deepanshu Kumar Chitra, Raj Kumar
Keyword: Pharmacovigilance, Adverse Drug Reaction, Adverse Events.
Page No: 201-212
Abstract: In recent years an increase in drug safety concerns, accompanied by some high profile drug withdrawals has steeped the bar of drug safety by various stakeholders, more significantly by the regulatory authorities. With the increasing reporting of Adverse Drug Reactions, volumes of data to be handled have simultaneously increased. Rapid detection of drug risks as well as the ability to defend the marketed product against an inappropriate serves as the essential expertise, skills, which are attained by those personnel having a sound understanding of Pharmacovigilance. The future path and providence of drug safety is solely dependent on Proactive pharmacovigilance throughout a product’s life cycle. In the context of clinical trials and post-marketing pharmacovigilance codification followed by standardization of the act of signal detection and risk management remains a great challenge in the progression and fluorishment of the field. Advancements of the discipline are at an infancy stage in India whereas the west has already reached the mountain in the same prospect. By the passage of time and with more clinical trials and clinical research activity being conducted in India, understanding and implementation of pharmacovigilance have become an essential need. A positive change can occur in Indian Scenario if the outlook of the workforce of regulatory agency (DCGIOffice) and the Indian Pharmaceutical companies is varied. This review describes and discusses the various policies and propositions to build, maintain and implement a stout pharmacovigilance system for various stakeholders and eventually make it functional in India. Key Words: Pharmacovigilance, Adverse Drug Reaction, Adverse Events. Download PDF