Validation: A Significant Tool for Enhancing Qualities of Pharmaceutical Products
N.V Satheesh Madhav, Abhijeet Ojha, Siddharth Singh
Sch Acad J Pharm | 288-296
DOI : 10.21276/sajp
Abstract
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Validation means confirmation of quality by with the documentation system. Quality is the main aspect of
every pharmaceutical company and it is achieved with the help of validation process. Validation is the documented
evidence that the process, procedure, activity or system operated within parameters, can perform effectively and
reproducibly to produce a desire quality product. It is a fundamental part of quality assurance because it provides
sensitivity, precision, efficiency, and reproducibility, at every stage of various processes which perform for different
requirements. Through this overview the writers take the time to provide a summary of validation concept of carrying out
validation trials and serve a perception to its significance in the pharmaceutical industry.
Hyphenated Techniques of Drug Analysis
Rageeb Md. Us man, Swap nil R. Badgujar, Tanvir Y. Shaikh
Sch Acad J Pharm | 263-272
DOI : 10.21276/sajp
Abstract
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A Hyphenated technique is combination or coupling of two different analytical techniques. Which is used as a
separation techniques and an online spectroscopic detection technology? . The remarkable improvements in hyphenated
analytical methods over the last two decades have significantly broadened their applications in the analysis of
biomaterials, natural products, elemental species, explosives, trace elements, etc. and show specificity and sensitivity. in
this article recent advance application about hyphenated techniques and information about analytical techniques, GCMS,CE-MS, LC-MS, LC-FTIR, LC-NMR, etc. the different areas like forensic science, environment, biotechnology,
geography, pharmaceutical etc. are discussed with appropriate examples for various purpose.
Original Research Article
June 21, 2017
Cardiac Tolerance of An Ethyl Acetate Extract of Holarrhena floribunda (G. Don) Durand and Schinz Leaves in Wistar Rats
D. D. Koudou, Tra-Bi Irie Otis, Oussou J.B, Kone Mama, A. P. Yapo, A. J. Djaman
Sch Acad J Pharm | 229-235
DOI : 10.21276/sajp
Abstract
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Holarrhena floribunda is a plant used in traditional medicine for the treatment of various pathologies.
However, it could cause toxic effects on the heart of patients. In order to determine its possible cardiotoxic effects, forty
rats were randomly grouped into 2 (control group and treated group), combined with 10 rats (control satellite group and
satellite treated group). Treated and satellite treated groups received, by gavage, 1000 mg / kg b.w. of the ethyl acetate
extract of the leaves of H. floribunda (EAHf). Control and satellite control groups were administered orally with distilled
water for 90 days. Animals blood samples were taken a day before the beginning of administration of H. floribunda and
every week during the first month and at the end of every month from the second month until the end of the experiment.
Serum was prepared for cardiac biochemical markers assay. The rats of the treated group at the end of the third month
and those of the satellite group at the end of the fourth month were euthanized using overdose of ether, the heart of the
rats was removed for gross morphology and histopathology analysis. The results of the biochemical parameters showed
that this extract induced a significant decrease (p <0.05) in total cholesterol, calcium, potassium and a significant increase
(p < 0.05) of HDL, sodium levels, and AST activities. On the other hand, ALT, LDH and CPK activities, and serum
triglyceride concentrations did not show any significant changes (p <0.05) in treated rats group compared to controls.
Microscopic observations of heart tissue sections of rats treated with the ethyl acetate extract of H. floribunda showed no
lesions, no edema, and no necrosis. These results suggest that H. floribunda did not interfere with functioning or altered
the integrity of the heart.
Gossypol: a potential promising anticancer agent
MUBANO Olivier Clément
Sch Acad J Pharm | 236-244
DOI : 10.21276/sajp
Abstract
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Despite the enormous amount of research and rapid developments seen during the past decades, cancer
continues to be a killer and a major public health problem worldwide. Gossypol, a polyphenolic compound derived from
cottonseeds, has been the target of many researches due to its multifaceted biological activities such as antifertility,
antivirus, antioxidant, antitryphagosomal, antimicrobial, antimalarial and most importantly anticancer activities. In
present review we summarized the results of studies obtained in a comprehensive search of Science Direct, PubMed,
Scirus, Springer LINK E-books and Web of Science. Basing on its mechanism of action and the synergy with other
anticancer agents we found gossypol to be a very good promising chemotherapeutic agent as it has shown its potentiality
in vitro, in vivo using animal models and in clinical trials against several different types of cancer.
Original Research Article
June 20, 2017
Design, In-Vitro Evaluation of Diclofenac Sodium Fast Disintegrating Tablets by Using Aegle Marmelos as a Natural Polymer
P.SS. Prasanna Kumar, G. Vijaya Kumar, N. Srinivas, B. Devaki Devi, A. Bhavani, G. Mohini Priya, A.Hemalatha, M. Anusha, M. Mrunalini, S.R.V.S.K. Mahalaxmi
Sch Acad J Pharm | 245-255
DOI : 10.21276/sajp
Abstract
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Diclofenac sodium is a non-steroidal anti-inflammatory drug with analgesic and anti-inflammatory properties
was selected as a model drug. The aim of the present work is to formulate a tablet which disintegrate, dissolve rapidly
and give its rapid onset of action. The present study was to formulate and in-vitro evaluation of fast disintegrating tablets
of Diclofenac sodium using fast disintegrating agents like Sodium Starch Glycolate, Crosspovidone and Natural polymer
such as Aegle marmelos (Bael Fruit) gum powder by direct compression technique in the concentration of 2%W/W,
4%W/W, 6%W/W & 8%W/W. Each formulation was evaluated for various pre and post compression parameters such as
Flow property, Bulk density, Tapped density, Weight variation, Hardness, Friability, Wetting time, Disintegration time,
Assay, in-vitro dissolution. Among the 12 formulations, F12 formulation Diclofenac sodium with 8%w/w of Aegle
marmelos showed better disintegration time and enhance the dissolution rate. From the In-Vitro dissolution rate studies
99.97% release of drug within 25 minutes and the mechanism of drug release from the tablets was followed to be first
order kinetics. FT-IR studies showed there was no interaction between the drug and polymers (or) excipients.
Original Research Article
June 23, 2017
Evaluation of Analgesic and Anti Inflammatory Activities of Ethanolic Extracts of Medicinal Plants Baccaurea ramiflora and Microcos paniculata
Suvendu Saha, T. Shivraj Gouda, S. Vijaya Srinivas
Sch Acad J Pharm | 256-262
DOI : 10.21276/sajp
Abstract
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Baccaurea ramiflora (family: Euphorbiaceae) is native to Southeast Asia region and is found distributed in the
sub-Himalayan tract, mainly from Nepal to Sikkim, Darjeeling hills, Arunachal Pradesh, Tripura, Assam, Bhutan,
Burma, Penninsular Malaysia, Tibet and Andaman islands. Microcos paniculata (family: Euphorbiaceae) is a shrub that is
abundant in secondary forests and also grown as hedges. As the oil of these plants is extensively used in number of
herbal preparation for curing inflammatory disorders, the present study was undertaken to assess analgesic and antiinflammatory activities of its leaves extracts. Dried and crushed leaves of Baccaurea ramiflora and Microcos paniculata
were defatted with petroleum ether and then extracted with alcohol. The alcoholic extract at the doses of 200 mg/kg, and
400 mg/kg body weight was subjected to evaluation of analgesic and anti-inflammatory activities in experimental animal
models. Analgesic activity was evaluated by acetic acid-induced writhing and hot plate methods in Swiss albino mice;
acute and chronic anti-inflammatory activity was evaluated by carrageenan-induced paw oedema and cotton pellet
granuloma in Wistar albino rats. Aspirin, Pentazocine and Diclofenac sodium were employed as reference drugs for
analgesic and anti-inflammatory studies, respectively. In the present study, the alcoholic leaves extracts of Baccaurea
ramiflora and Microcos paniculata demonstrated significant analgesic and anti-inflammatory activities in the tested
models
Original Research Article
June 28, 2017
Study of Effect of Dexmedetomidine and Clonidine as Adjuvant with Bupivacaine on the onset & Duration of Analgesia and Anaesthesia in Supraclavicular Brachial Plexus Block
Harekrishna Ray, Kamala Kanta Pradhan, Soumyakant Sethi, Amulya Ranjan Dash
Sch Acad J Pharm | 273-280
DOI : 10.21276/sajp
Abstract
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Many adjuvants have been used with local anaesthetics to reduce the time of onset and prolong the duration of
analgesia in brachial plexus blocks. Very few studies are there comparing dexmedetomidine versus clonidine as adjuvant.
This study was done to compare the effects of dexmedetomidine and clonidine as adjuvant to local anaesthetics in
supraclavicular block. In this double blinded clinical trial, 90 ASA classes I and II patients posted to undergo upper
extremity surgery were divided into 3 different groups randomly. Group C patients received 35 ml of 0.25% bupivacaine
and Clonidine (1 mcg/kg), Group D patients received 35 ml of 0.25% bupivacaine and Dexmedetomidine (1 mcg/kg),
while group B received 35 ml of 0.25% bupivacaine only in supraclavicular brachial plexus block. Time of request for 1st
rescue analgesia, onset and duration of sensory motor blocks and changes in hemodynamic parameters were studied and
analyzed. Time for request for rescue analgesia was delayed in group D compared to group B and C. The mean of
sensory and motor block onset time in group D was less than in group B and C, the difference between the two group
being statistically significant(p<0.001).In group D mean duration of sensory block was prolonged compared to group B
and C, which was statistically significant(p<0.001). The addition of dexmedetomidine as adjuvant to bupivacaine in
brachial plexus blockade delayed the requirement of rescue analgesia with decreased onset time and prolonged duration
of sensory and motor block characteristics compared to clonidine
Original Research Article
June 29, 2017
Formulation and In-Vitro Evaluation of Capsaicin Emulgel for Topical Delivery
K. Navaneetha, Asma Begum, P.Sumalatha, D.Vinitha, J. Sravan and Krishna Mohan Chinnala
Sch Acad J Pharm | 281-287
DOI : 10.21276/sajp
Abstract
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Emulgels are topical dosage form in which emulsions are gelled by mixing with gelling agent. Incorporation
of emulsion into gel increases stability of emulsion and provides controlled release system. Emulgels have emerged as a
promising drug delivery system for the delivery of hydrophobic drugs. The main objective of the present study is to
prepare emulgel using capsaicin, an analgesic as drug of choice. Liquid paraffin was used as oil phase of o/w emulsion
and combination of Span 80 and Tween 80 were used as emulsifying agent and clove oil was used as permeation
enhancer. Polymers like carbopol 974, carbopol 930, HPMC K100, HPMC K4M and HEC are used as gelling agent in
various proportions. Total of 7 formulations were prepared by changing the gelling agent and their concentration. The
prepared emulgels were evaluated for physical appearance, pH, spreadability co-efficient, physical stability, drug content,
skin irritation test and in-vitro drug release. All the formulations were physically stable with the pH values within the
range and have shown good spreadability coefficient. There was no irritation or swelling observed in the rats during the
test period. In-vitro diffusion studies were carried out using pH 7.4 phosphate buffer and formulation F1 (Carbopol 974-
1%) has shown best results with zero order release kinetics and diffusion mechanism