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REGULATORY CANVAS OF INDIAN PHARMACEUTICAL INDUSTRY: CHALLENGES AND FUTURE

ABOUT AUTHORS
Ayushi Srivastava*, Veena Gupta
QC Department,
Akums Drugs & Pharmaceuticals Ltd, Haridwar, India
*ayushisr@gmail.com

ABSTRACT
This article undertakes a review and assessment of regulatory framework in the Indian pharmaceutical industry. Understanding the regulatory circumstances in this segment is extremely critical. The Pharmaceutical industry is one of the major industries in India and it contributes a large share in the overall macro level growth of the India. It is one of the most dynamic sectors in the country but its compliance structure is more complex. The pharmaceutical industry has always been a buoyant sector in the eyes of Investors. With increasing returns, lower risks and high growth, investors are more interested in this industry than ever before.


A REVIEW ON: PRESERVATIVES USED IN PHARMACEUTICALS AND IMPACTS ON HEALTH

ABOUT AUTHORS
Sabir M. Shaikh*1, Rajendra C. Doijad1, Amol S. Shete1, Poournima S. Sankpal2
1 Department of Pharmaceutics, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
2 Department of Pharmaceutical chemistry, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
*sabirmshaikh17@gmail.com

ABSTRACT
For several decades pharmacist have been aware of the need to protect their products against microbial contamination but it is only during the last one or perhaps two decades the serious thought of has been applied to the science of preservation. Preservatives are commonly used as additives in pharmaceutical products, food and cosmetics. Some of the liquid preparation are susceptible to microbial contamination because of the nature of ingredients present in it. Such preparation are protected by preservatives which avoids degradation and alteration of the product.A preservative is a natural or synthetic chemical added to various products which helps to prevent microbial decomposition. Present article deals with the study of ideal properties, classification, mechanism of action, Pharmaceutical applications and its impact on health of various preservatives used in pharmaceuticals.


RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF MEBENDAZOLE IN API AND PHARMACEUTICAL FORMULATIONS

ABOUT AUTHORS
Durgesh Rameshlal Parakh1*, Jayshri K. Madagul1, Harshad Rajendra Mene2, Moreshwar P. Patil1, Sanjay J. Kshirsagar1
1
Department of Pharmaceutics,
MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, India.
2
Department of Pharmaceutics,
Government College of Pharmacy, Osmanpura, Aurangabad, Maharashtra, India.
*aryanparakh57@gmail.com

ABSTRACT
A new simple and sensitive RP-HPLC method was developed and validated for quantification of Mebendazole in Active Pharmaceutical Ingredient (API) and pharmaceutical formulation.The gradient RP-HPLC method was developed on Agilent (India) C18 250 × 4.6 mm, 5 μ column using mobile phase as acetonitrile: water pH 3.0 with orthophosphoric acid (90:10 v/v) at a flow rate of 1 mL/min and detection was carried out at 234 nm using UV-Visible detector (UV 3000 M). The method was validated linearity, limit of detection, limit of quantification, precision, ruggedness, robustness, accuracy and specificity were found to be satisfactory. The method was found to be linear in the concentration range of 20-100 μ/mL with correlation coefficient of 0.999. The method was validated according to the ICH guidelines and was proved to be specific, linear, accurate, precise and economical for the analysis of Mebendazole.


DATA INTEGRITY AND WORLDWIDE REGULATORY GUIDANCE

ABOUT AUTHORS
Rohit A. Patil1*, Shruti N.Patil2

Department of Regulatory Affairs,
Supreme Pharma Healthcare Pvt. Ltd. Mumbai, MH, India
* rohitpharma3250@gmail.com

ABSTRACT
Good storage of data & record management are critical elements of pharmaceutical quality system. Data integrity refers to maintaining & assuring the accuracy & consistency of data over its entire life –cycle in compliance with its applicable regulatory requirements.
Data integrity is mandatory for the regulated pharmaceutical industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported. Data integrity risk should be assessed, mitigated, communicated & reviewed throughout the data life cycle. Healthcare industries should be designed Record-keeping methodologies and systems, in a way that encourages compliance and assures data quality and reliability.


ZERO ORDER AND FIRST ORDER DERIVATIVE SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF MOXIFLOXACIN HYDROCHLORIDE AND KETOROLAC TROMETHAMINE IN SIMULATED TEAR FLUID

ABOUT AUTHORS:
Shashank Nayak N*1, U Srinivasa2, Shwetha S Kamath K3, Shabaraya AR4
1Dept of Pharmaceutics, Pacific university, Udaipur, Rajasthan
2Dept.of Pharmacognosy, Srinivas college of pharmacy, Mangalore, Karnataka
3Dept. of Pharmaceutics, Srinivas college of pharmacy, Mangalore, Karnataka
4Principal, Srinivas College of Pharmacy, Mangalore, Karnataka
shashanknayak87@gmail.com

ABSTRACT
In this current work simultaneous estimation of Moxifloxacin HCL and Ketorolac tromethamine in simulated tear fluid was performed by using UV spectroscopy. The zero order derivative spectroscopy revealed that Moxifloxacin HCL had a λ max of 288 nm in Simulated tear fluid (STF) and Ketotorolac tromethamine had λ max of 322nm respectively. The linearity was found in the range of 2-10 µg/ml for Moxifloxacin HCL and 2-14µg/ml for ketorolac tromethamine.  The R2 value was found to be 0.998 and slope y=0.089 for Moxifloxacin HCL and R2 =0.998 and slope y=0.051 for Ketorolac tromethamine. The zero order spectrum was deravatized to first order derivative spectra for both the above mentioned drug. The first order derivative spectra of Moxifloxacin HCL and ketorolac tromethamine indicated that it had a zero crossing point (ZCP) at 286 nm and 328 nm. The absorbance of the mixture containing MOXI and KETO was found out at 286 nm and 328 nm which showed linearity and obeyed beers lamberts law.


BIO-MARKERS AND BIO-SENSORS: UNRAVELLING THE MAJOR MECHANISTIC INTERVENTIONS IN CANCER PROGNOSIS

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ABOUT AUTHOR
Rajesh Tiwari
Junior Technical Assistant
Pharmaceutical Science and Natural Products
Central University of Punjab, Bathinda
rajesh.tiwari851@gmail.com

ABSTRACT
Biosensors are a tool that combines the biochemical element with a transducer that generates an indication for the identification of disease. Numbers of biosensors are used in different medical application. Biomarker and Biosensors play an important role for early stage exposure of cancer. It is a cost-effective, increased assay speed, resiliency, the ability for multi-target analysis method. Genomic and proteomic molecular tools are also used for the exposure of tumors. These methods produce a molecular mark that provides a new opening for utilizing biosensors and biomarkers. As with many disease conditions, it is not easy to find exact and responsive markers that are associated with only one marker. Different numbers of molecular signatures are used for the diagnosis of cancer, such as proteins, peptides, overexpression gene and gene mutation. This review provides a general idea of the biosensors and biomarkers technology that is currently developed and researched for cancer markers and diagnosis.


AN OVERVIEW ON NIOSOMES A NOVEL VESICULAR APPROACH FOR OPHTHALMIC DRUG DELIVERY

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ABOUT AUTHORS:
Anupriya Kapoor
University Institute Of Pharmacy,
Chhatrapati Shahu Ji Maharaj University, Kanpur
anupriya321@gmail.com

ABSTRACT
Non-ionic surfactant vesicles (Niosomes or NSVS) are widely studied as an alternative to hydrated surfactant monomers. Non-ionic surfactants of wide structural types have been found to be useful alternatives to phospholipids in fabrication of vesicular system. They are the microlamellar structures formed by the mixing of Non-ionic surfactant of alkyl or dialkyl polyglycerol ether class and cholesterol with subsequent hydration in aqueous media. This review article deals with the detailed use of Niosome as novel drug delivery system for ophthalmic use, since this route is most frequently used for the treatment of eye infection.


REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN CHINA

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ABOUT AUTHORS:
Jitendra Kumar Badjatya
Deputy Manager-DRA,
Montajat Pharmaceutical Company Limited, Dammam, KSA
jeetbadjatya@gmail.com

ABSTRACT
A Generic Product must meet the standards established by China Food and Drug Administration (CFDA) to be approved for marketing in China respectively. This study covers the introduction to generic drugs, in China regulatory authorities. It also includes the requirements and registration of Generic Drugs.
Many large pharmaceutical companies have increased their presence in emerging markets in recent years like China markets is predicted to be the second largest market after US in Pharmaceuticals. China is moving past its phase as a supply market for ingredients and generic finished drugs. So, is more important to know about Regulatory considerations and Registration process of Generic Drugs. This article focuses in particular on pharmaceuticals companies, the Registration process of Generic Drugs, and their activities in the China.


FORMULATION AND EVALUATION OF GASTRORETENTIVE HYDROCHLOROTHIAZIDE FLOATING MICROSPHERES: STATISTICAL ANALYSIS

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ABOUT AUTHORS:
Y. Veda Pravallika* , K.Rajyalakshmi
Bapatla college of pharmacy,
Bapatla, Andhra Pradesh
yadlapallivedapravallika@gmail.com

ABSTRACT:
The main objective of this work is to formulate gastroretentive floating microspheres of hydrochlorothiazide and to study the effect of formulation variables like drug to polymer ratio and concentration of polymer dispersion. The hydrochlorothiazide floating microspheres were formulated by using orifice-ionic gelation technique. These microspheres were formulated by using sodium alginate as sustained release polymer, sodium bicarbonate as gas generating agent and calcium chloride as a cross linking agent. The rheological properties of the polymer dispersion were studied. The microspheres were formulated by different drug to polymer ratio’s at various concentrations of sodium alginate dispersion. Thus formulated microspheres were evaluated for floating behaviour, drug entrapment efficiency, drug content, micromeritic properties, particle size, swelling index, invitro drug release studies and release kinetics. The better formulation was subjected for stability studies and SEM analysis. The effect of formulation variables on the entrapment efficiency and release rate constant was studied by statistical analysis. The hydrochlorothiazide microspheres formulated with 1:3 drug to polymer ratio and 3.5% sodium alginate dispersion concentration was selected as optimized formulation based on the results.


A REVIEW AND APPLICATION OF CRYOPROTECTANT: THE SCIENCE OF CRYONICS

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ABOUT AUTHORS:
Ankit J. Joshi
Department of Pharmaceutics & Pharmaceutical Technology,
S. K. Patel College of Pharmaceutical Education and Research,
Ganpat University, Ganpat vidyanagar, Kherva, Mehsana-Gozaria Highway, Gujarat.
Joshiankit2824@gmail.com

ABSTRACT
The preservation of cells, tissues and organs by cryopreservation is promising technology now days and Low temperature technology has progressed in the field of tissue engineering, food preservation, fertility preservation, making disease resistant breeds since the early years to occupy a central role in this technology. Cryopreservation is important technology in every field like in organ cryopreservation, food cryopreservation, human cryopreservation, seeds cryopreservation, protein cryopreservation and pharmaceuticals. Cryobiologists will be required to collaborate with new physical and molecular sciences to meet this challenge. How cryoprotectants work is a mystery to most people. In fact, how they work was even a mystery to science until just a few decades ago. This article will explain in basic terms how cryoprotectants protect cells from damage caused by ice crystals, and with some of the advances.


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