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A REVIEW ON SINGLE USE DISPOSABLE TECHNOLOGY FOR RECOMBINANT PROTEIN MANUFACTURING

ABOUT AUTHOR
Madhusudan P Dabhole
Group Manager – BioProcess,
Richcore Life Sciences Ltd, Bangalore, Karnataka, India
madhav888@rediffmail.com

ABSTRACT
The manufacturing of recombinant products by fermentation and purification in stainless steel vessels has seen the transition from small scale to large scale and further to single use disposable technology. The requirement to develop and modulate the process has arisen from the cost and manufacturers need to move the facility on mobile platforms. The review describes the strategies and considerations for Single Use Disposable Technology. Recombinant proteins are widely used for treatment of various diseases and disorders. Single Use Disposable Technology makes it promising to produce and formulate these proteins from bench scale to commercial level in a shorter span of time so that it can reach the physician and patients.


HEPARIN: POWERFUL AND INSTANTANEOUSLY ACTING ANTICOAGULANT

ABOUT AUTHOR
Amitava Sinha Ray
Ranbaxy Laboratories Ltd
West Bengal, India
a.amitava.s@gmail.com

ABSTRACT
Anticoagulantis an agent that is used to prevent the formation of blood clots. Anticoagulants, such as heparin or warfarin work on chemical reactions in the body to lengthen the time it takes to form a blood clot. Heparin the anticoagulant drug that is used to prevent blood clots from forming during and after surgery and to treat various heart, lung, and circulatory disorders in human body. Heparin is comparatively a strong acid that forms water–soluble salts. It is used in treatment of venous thrombosis and its extensions, pulmonary embolism (PE), peripheral arterial embolism. Smoking and alcohol may alter response to heparin. Abrupt withdrawal of heparin may precipitate increased coagulability.


DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF MANIDIPINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

ABOUT AUTHORS
Bhavik S. Patel*, Chetan A. Prajapati
Department of Quality Assurance
Pacific College of Pharmacy, Udaipur, Rajasthan, India
*bhavikpatel412@gmail.com

ABSTRACT
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for determination of Manidipine HCL. novel stability-indicating RP-HPLC method has been develop and validated for quantitative analysis of Manidipine HCL in in its pharmaceutical dosage forms using Column -Inertsil ODS 3v column (150 mm x 4.6 mm i.d., 5 μm)  with Phosphate buffer (pH-2.2) : Acetonitrile (60:40) as isocratic mobile phase at a flow rate of 1.4 ml/min and wavelength of 228 nm. The calibration curves were linear over the concentration ranges of 20-150 μg/ml for Manidipine HCL. The limit of detection (LOD) and limit of quantification (LOQ) for Manidipine HCL were 0.48 and 1.47 μg/ml.Recovery of Manidipine HCL the pharmaceutical dosage form ranged from 99.89-100.71%.
Manidipine HCL was subjected to stress conditions (Hydrolysis (acid, base), oxidation, thermal and photo degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H2O2.


ANTACIDS: HEART BURN OTC DRUGS

ABOUT AUTHORS:
Tribhuvan Patel*, Virendra Kr. Baheliya, Rajesh Kr. Prajapati, Vivek Kr. Yadav, Avanish Kr. Yadav, Pramod Kr. Jaiswal
Department of Pharmaceutical Sciences,
Kunwar Haribansh Singh College of Pharmacy, Jaunpur, U.P.
*vikashk464@gmail.com

ABSTRACT
Antacids are chemical substances which neutralizing the acid that causes heartburn. By reducing the acidity, the acid is less able to irritate the esophagus. The effect of antacids on the stomach is due to partial neutralisation of gastric hydrochloric acid and inhibition of the proteolytic enzyme, pepsin. There are commonly used self-prescribed medications.  Antacids are available many forms such as suspensions, chewable tablets and liquid gels. They consist of calcium carbonate and magnesium and aluminum salts in various compounds or combinations. Antacids are used for gastric and duodenal ulcers, gastro-oesophageal reflux disease, stress gastritis, pancreatic insufficiency, non-ulcer dyspepsia, biliary reflux, bile acid mediated diarrhoea, constipation, osteoporosis, urinary alkalinisation and chronic renal failure as a dietary phosphate binder.


A REVIEW ON EBOLA VIRUS DISEASE

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ABOUT AUTHORS:
Rathore KS*, Roshan Keshari, Annu Rathore, Divya Chauhan
BN Institute of Pharmaceutical Sciences,
Udaipur, Rajasthan, India
kamalsrathore@gmail.com

ABSTRACT
The Ebola virus (formerly officially designated Zaire ebolavirus, or EBOV) was first seen infecting humans in African continent; especially Sudan, Democratic Republican of Congo, Zaire and nearby countries. Fruit bats of the Pteropodidae family are considered to be the natural host of the Ebola virus. In the current outbreak, most cases are the result of human-to-human transmission, when there is direct contact with bodily fluids, secretions, the mucous membrane or broken skin of an infected person. The disease typically occurs in outbreaks in tropical regions of Sub-Saharan Africa. The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. But now, the virus seems to have enthralled the global interest due to its lethal prospective. EVD outbreaks have a case fatality rate of up to 90%. The research is ongoing on development of making vaccine to curb this virus yet licensed success or specific treatment is not achieved. Severely ill patients require intensive supportive care.


AN INSIGHT ON RAYNAUD’S DISEASE: CAUSES, SYMPTOMS, DIAGNOSIS, TREATMENT AND PREVENTION

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ABOUT AUTHORS:
*Roshan Keshari1, Sonika Shrivastava2, Rathore KS1
1BN Institute of Pharmaceutical Sciences, Udaipur-Rajasthan, India
2KD Dental College and Hospital, Mathura-UP, India
roshankeshari@gmail.com

ABSTRACT
Raynaud’s disease is illustrated by a pale to blue to red series of color changes of the digits, most commonly after exposure to cold. Raynaud’s phenomenon is a state of the flow that affects blood deliver to the skin and causes the extremities of the body to drop feeling and become numb also paroxysmal paleness and coldness of the extremities. Total 5-6% of global population is affected by this illness. Symptoms of Raynaud’s phenomenon depend on the severity, incidence, and length of the blood-vessel spasm. There is no blood test for diagnosing Raynaud’s phenomenon.

Certain Synonyms of Raynaud’s phenomenon: systemic lupus erythematosus, microcirculation and vasoconstriction. Raynaud’s disease is of two types: Primary Raynaud’s phenomenon or idiopathic is considered the more frequent, milder condition. There is no underlying disease associated with the primary classification. About 75-80% of all cases diagnosed happen in women between 15 and 40years elderly. Another is Secondary Raynaud’s phenomenon is not so frequent, but is considered the more severe of the two types. It is associated with an underlying disease, most commonly, one of the connective tissue diseases

The risk factors include: smoking, working with vibrating machinery - the fingers may go into spasm. This is due to an intermittent lack of blood supply to the fingers and emotional distress, exposure to the cold; women are affected more often than men. Management of Raynaud’s disease is possible with medical, nursing, pharmacological, and surgical way.


FORMULATION EVALUATION AND OPTIMIZATION OF MEBENDAZOLE COLON TARGETED SUSTAIN RELEASE PELLETS BY EXTRUSION SPHERONIZATION

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ABOUT AUTHORS:
Raval Aniket*, Chauhan Sachin P., Sheth A.K, Shah Nirmal, Aundhia Chintan
Department of Pharmacy, Sumandeep Vidyapeeth University,
At & Po Pipariya, Ta. - Waghodia, Dist. Vadodara, Gujarat, India
aniket_raval2006@yahoo.co.in

ABSTRACT:
The aim of present investigation is to formulate evaluate and optimization of colon targeted pellets bearing mebendazole, benzimidazole derivative with broad spectrum of anthelminthic activity. It is highly effective against adult and larval stages of ascaris lumbricoids, hook worms and  indicated for the treatment of nematode infestation. Pellets were prepared by extrusion spheronization process using microcrystalline cellulose as spheronizing aid, natural polysaccharide pectin as binders in three different percentages i.e 5%, 10% and 15% and glycerine as plasticizer.  Further study was carried out to select the natural polysaccharide for formulation of colon targeted pellets i.e. Pectine, Xanthan gum and Guar gum. The formulation were prepared with optimized constant process parameters i.e. Percentage LOD 10%, Spheronization time 3 minutes and Speed of spheronization 700-1200 rpm. Prepared A1 – A9 batches were then evaluated by their micromeritic properties like tapped density, carr’s index, hausner, S ratio, angle of repose  and characterized by microscopic study, % yield, hardness, friability, % assay and dissolution study was carried out and compared with marketed formulation by statistical analysis similarity factor (f2). The batch A5 is having 10% pectin, 18% MCC and 20% mebendazole shows (22.20±2.05) % carr’s index, (1.22±0.04) hausner’s ratio, (26.65±1.15) angle of repose, (88.2±2.36) % yield, (3.96±0.46) hardness, (0.23±0.03) % friability  (88.47±3.26) % assay and (99.81±3.80) % drug release after 10 hours. Pellets equivalent to 300mg of mebendazole  were then filled in capsules and capsules coated with 12.5% w/v Eudragit S 100 using optimized 4- 5 ml/min spray rate, 15 rpm pan speed and 40±5°C coating inlet temperature and then optimized for % weight gain in four different trials. W2 batch having 10% weight gain were then evaluated by % cumulative drug release, disintegration test in 0.1 N HCl shows (99.73±3.34) % CDR, intact after 12 hours. The pellets of batch A5 and the enteric coated capsule with 10 % weight gain were packed in aluminum pouch and charged for accelerated stability studies at (40°C±2°C) and (75%±5%) RH for 1 month in a stability chamber shows no change in the dissolution profile at (40°C±2°C) and (75%±5%) RH storage condition.


A REVIEW: DETERMINATION OF ITOPRIDE HYDROCHLORIDE IN BIOLOGICAL FLUID AND PHARMACEUTICAL DOSAGE FORMS

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ABOUT AUTHORS:
Asif I Bhim*, Vineet Jain, Hasumati Raj
Shree Dhanvantary Pharmacy College,
Kim, Gujarat, India
bhimiqbal23@gmail.com

ABSTRACT:
Itopride Hydrochloride is a novel, synthesized, gastro prokinetic drug, which stimulates gastrointestinal motor activity through the synergistic effects of dopamine D2-receptor blockade and acetylcholine esterase inhibitors. Chemically, it is N-[[4-[2-(Dimethyl amino) ethoxy] phenyl] methyl]-3, 4-dimethoxy benzamide hydrochloride. Benzamide structure, amide and ether linkages in the drug molecule make it susceptible to degradation. Thus a prokinetic drug like Itopride Hydrochloride by virtue of its efficacy and tolerability could be considered as a drug of first choice and a welcome addition to the drug armamentarium for the symptomatic treatment of NUD (non-ulcer Dyspepsia) and other gastric motility disorders including functional bowel disorders. This review consists of various analytical methods for determination of Itopride Hydrochloride in various marketed pharmaceutical preparation and in biological fluids. Analytical method consists of various spectroscopic methods, chromatographic methods and other methods.


ALTERNATIVES TO THE DRAIZE EYE TEST

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ABOUT AUTHOR:
Bushra Shamim
Department of Pharmaceutics,
Faculty of Pharmacy,
Hamdard University, New Delhi.
bushrashamim21@gmail.com

ABSTRACT
Industry and regulatory bodies responsible for public health are actively assessing animal free tests to reduce the requirement for Draize testing. Draize rabbit eye irritation test developed in the 1940’s is even today the only eye toxicity test officially accepted in the OECD countries for regulatory purposes in the classification of slightly and moderately irritating chemicals. The Draize test has been widely criticized for both scientific and ethical reasons, and alternatives have been investigated for several decades. Therefore in an attempt to minimize this conflict alternative methods have been investigated. This article presents those alternative methods that are currently the most developed and the most widely used.


DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND DAPOXETINE HYDROCHLORIDE INCOMBINED DOSAGE FORM

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ABOUT AUTHORS:
Chetan A. Prajapati*, Bhavik S. Patel, R.Badmanaban
Department of Quality Assurance, Shri Sarvajanik Pharmacy College,
Mehsana, Gujarat, India
*prajapatichetan25@gmail.com

ABSTRACT
A novel, precise, accurate and economic high-performance thin-layer chromatographic (HPTLC) method was developed, optimized and validated for simultaneous determination of Sildenafil Citrate and Dapoxetine Hydrochloride. The chromatographic separation was performed on precoated silica gel 60 GF254 plate with hexane: methanol: diethyl amine 9.2:1.6:1.2 (v/v/v) as mobile phase. The plate was developed to distance of 8.0 cm at ambient temperature. The developed plate was scanned and quantified at their single selected wavelength of 241 nm for Sildenafil Citrate and Dapoxetine Hydrochloride. Experimental conditions such as band size, chamber saturation time, migration time of solvent front, etc. were critically studied and the optimum condition were selected. The drugs were satisfactorily resolved with RF 0.21 ± 0.02 for Sildenafil Citrate and 0.72 ± 0.02 for Dapoxetine Hydrochloride. The method was validated for linearity, accuracy, precision, and specificity. The calibration plot was linear between 2000–12000 ng per spot for Sildenafil Citrate and 1200–7200 ng per spot for Dapoxetine Hydrochloride. The limits of detection for Sildenafil Citrate and Dapoxetine Hydrochloride were 210 and 75ng per spot respectively and limit of quantification for Sildenafil Citrate and Dapoxetine Hydrochloride were 450 and 240ng per spot respectively. It is a user-friendly and important tool for analysis of combined fixed dosage forms. Methods were validated statistically and recovery studies were carried out. The method herein described can be employed for quality control and routine analysis of drugs inpharmaceutical formulations.