Articles

28 May 2011

Analytical Method Development and Validation for Pre - Clinical Analysis

About Author: Kale Vishal Bibhishan
Department Of Pharmacy, School Of Chemical Engineering and Bio-Technology
SASTRA UNIVERSITY, Thanjavur-613402, Tamil Nadu, INDIA

Reference ID: PHARMATUTOR-ART-1064

Abstract
Pre-clinical phase is a laboratory test of a new drug on animal subjects, conducted together evidence justifying a clinical trial. For those drugs which are in clinical phase, method development requires various pre-clinical bioanalytical support parameters. Bioanalytical support plays a pivotal role in answering a series of questions concerning the toxicity, pharmacokinetic parameters, safety assessment, formulation optimization .Once method development process was initiated one should know the different techniques of sampling, handling, sample preparation methods that are suitable and problems in it. After sample preparation, suitable analytical techniques have to be selected for method development. The developed method now have to be validated, for this, Initially “Analytical Instrument Qualification” has to be performed which includes four main phases- Design qualification, Installation qualification, Operational qualification and Performance qualification. Method is said to be validated when all considered validation parameters like linearity, specificity, selectivity etc are within the limits. Thus the method is developed and validated for a drug in preclinical phase using analytical technique of suitable sensitivity and selectivity.
28 May 2011

DEVELOPMENT AND VALIDATION OF SITAGLIPTINE BY VISIBLE SPECTROPHOTOMETRIC IN BULK AND PHARMACEUTICAL DOSAGE FORMS

About Author: V. Ranjith Kumar*, Chintalapti Sujitha
* Department of Pharmaceutical Analysis,
Priyadarshini college of Pharmaceutical Sciences,
Chowdaryguda, Narapalli, Ghatkesar (Mo),
RR-District-501301. AP-INDIA.

Reference ID: PHARMATUTOR-ART-1062

Abstract
A simple, accurate, cost effective and reproducible spectrophotometric method has been developed for the estimation of Sitagliptine in bulk and pharmaceutical dosage form. Visible spectrophotometric method, which is based on measurement of absorption at maximum wavelength 540 nm. The accuracy of the methods was assessed by recovery studies and was found to be ranging from 99.5-101.5 .The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. Beers law was obeyed in the concentration range of 25-125 µg/ml having line equation y = 0.026x + 0.016 with correlation coefficient of 0.999. Results of the analysis were validated statistically and by recovery study.
23 May 2011

BIOTECH SOLUTION TO HEALTH CARE CHALLANGES

About Author: DEDAKIYA ARJUN S.*, BANDHIYA HEMANT M., VIPUL P. PATEL, TUSHAR R. DESAI2
1. Assistant professor, Department of pharmaceutics, R. K. College of Pharmacy, Kasturbadham,Rajkot.
2. Principal, Department of pharmacology, R. K. College of Pharmacy, Kasturbadham,Rajkot.
3. Research Scholar, R. K. College of Pharmacy, Kasturbadham, Rajkot

Reference ID: PHARMATUTOR-ART-1061

Abstract
This article provides a basic view of what defines biological medicinal Products, often called biologicals, and how they differ from chemical products. In entering into this thought process, let us remember that proteins range in size from small amino acid chains up to macromolecules of hundreds of kilodaltons in size. In addition, in order to appreciate the science behind the regulations, an understanding of organic chemistry is necessary, and preferably knowledge of molecular cell biology and how proteins are created in cells via the DNA expression mechanisms. Although the details are inevitably complex and specialist as a result, we will look at some basic concepts pertinent to biologicals so that a regulatory generalist can be effective in dealing with such products.
22 May 2011

PULSATILE DRUG DELIVERY SYSTEM: A REVIEW

About Author: VIPUL P. PATEL1*, TUSHAR R. DESAI2, CHETAN R. MATHOLIYA, RAVI B. CHHAYANI
1. Assistant professor, Department of pharmaceutics,
R. K. College of Pharmacy, Kasturbadham,Rajkot.
2. Principal, Department of pharmacology,
R. K. College of Pharmacy, Kasturbadham,Rajkot.
3. Research Scholar, R. K. College of Pharmacy, Kasturbadham, Rajkot.

Reference ID: PHARMATUTOR-ART-1060

Abstract
Pulsatile Drug Delivery Systems are gaining a lot of interest as they deliver the drug at the right place at the right time and in the right amount, thus providing spatial and temporal delivery and increasing patient compliance. These systems are designed according to the circadian rhythm of the body. The principle rationale for the use of pulsatile release of the drugs is where a constant drug release is not desired. A pulse has to be designed in such a way that a complete and rapid drug release is achieved after the lag time. Various systems like capsular systems, osmotic systems, single- and multiple-unit systems based on the use of soluble or erodible polymer coating and use of rupturable membranes have been dealt with in the article. It summarizes the latest technological developments, formulation parameters, and release profiles of these systems. These systems are beneficial for the drugs having chronopharmacological behavior where night time dosing is required, such as anti-arhythmic and anti-asthmatic. Current review article discussed the reasons for development of pulsatile drug delivery system, types of the disease in which pulsatile release is required, classification, advantages, limitation, and future aspects of pulsatile drug delivery system.
21 May 2011

Novel Targeted Drug Delivery Systems - New Age Weapons for Bladder Diseases.

About Author: Parikh Ankitkumar Yogeshbhai*, Joshi Pratikkumar Rajendrakumar, Upadhyay Shivam Umeshbhai
*Department of Pharmaceutics,
A. R. college of Pharmacy,
V. V. Nagar, Anand, Gujarat, India.

Reference ID: PHARMATUTOR-ART-1073

Abstract
The urinary bladder is primarily a short-term storage organ for urine. The epithelial layer of the urinary bladder, the urothelium, serves as the primary barrier to the toxic substances diffusing from the urine into the blood. The barrier function is due to the epithelial surface of the urinary bladder, the urothelium, which has characteristic umbrella cells, joined by tight junctions and covered by impenetrable plaques, as well as an anti-adherent mucin layer. Diseases of the urinary bladder, such as bladder carcinomas and interstitial cystitis, cause acute damage to the bladder wall. They cannot be effectively treated by systemic administration of drugs because permeability of the urothelial layer is very low and instilled drug solutions become diluted with urine and get washed out of the bladder during voiding, necessitating repeated infusions of the drug. In order to improve the efficacy of drug carrier systems for drug delivery purposes, nano-sized particles such as liposomes, polymeric nanoparticles, gelatin protein nanoparticles, dendrimers, etc., can be used to increase the contact between the encapsulated drug and the damaged site, as well as chemically interact with the urothelium to enhance permeability through it. Magnetic targeting using external magnetic fields shows promising results in terms of non-invasive targeting of specific regions in the bladder. Mucoadhesive biomaterials as drug carriers can adhere efficiently to the mucous membrane of the urothelium, increases the residence time of the drug in the bladder and allows sustained drug delivery over a prolonged time span. Hydrogels, such as the thermo-responsive polymeric PEG-PLGA-PEG system, which forms an in situ polymeric gel layer that stays strongly adhered to the bladder wall. Gene therapy using viral and non-viral vectors has advantages over conventional methods in terms of much more specific targeting of tumor cells. Novel targeted drug delivery systems with much higher specificities to the target cells can provide great breakthrough in bladder diseases, especially bladder cancers which are difficult to treat currently and having high mortality rates.
15 May 2011

ALTERNATIVES TO ANIMAL TESTING: A VANTAGE OVER ANIMAL MODELS

About Author: Tapan Behl*, Neha Chauhan, Harlokesh Narayan Yadav
Department of Pharmacology,
I.S.F. College of Pharmacy,
Moga - 142001, Punjab, India

Reference ID: PHARMATUTOR-ART-1063

Abstract
Animal testing had been in practice from the last many decades. Animal testing and experimentation leads to killing and cruelty of hundreds of thousands of animlas each year. Misconception is so much about the general public that the use of animals is considered mandatory for meeting the learning objectives. The existence of methods like In vitro pyrogen test, embryonic stem cell test, carcinogenicity test etc. has paved the good pathway for the usage of alternatives to animal experimentation. Alternatives to animal experiments can only be put into practice by the general awareness of the public about the animal welfare, the tediousness of the animal methods, and the expensive and time consuming nature of these methods. In this review a various alternative testing methods are discussed so that pavement should be directed into a meaningful research, healing and protection and is mandatory for restoring faith and respect in medical profession. This review will provide an insight on the various alternatives to animal experimentation so that a path can be lighted which would be terror free and without dragging the animal to a life of horror and unbearable pain.

[adsense:336x280:8701650588]
15 May 2011

EDIBLE VACCINE - A GREAT BOON IN MEDICINAL SCIENCE

About Author: Mr.Mahendra G. Pawar* (B.Pharmacy) Ms.Komal R. Nikam (B.Pharmacy), Mr.Rakesh D.Amrutkar (M.Pharmacy)

Reference ID: PHARMATUTOR-ART-1059

Abstract
Biotechnologists in recent years have come up with a new concept.This new concept is about edible vaccine. The difference here lies, that crops like “golden rice” provided extra nutrition that naturally didn’t occur in it. But edible vaccines are GM crops that would provide extra added “immunity” from certain diseases.
Edible vaccines are composed of antigenic proteins and do not contain pathogenic genes (because obviously they use attenuated strains). Thus, they have no way of establishing infection and safety is assured.Oral administration is possible , production is highly efficient and can be easily scaled up.For example, hepatitis-B antigen required to vaccinate whole of China annually, could be grown on a 40-acre plot and all babies in the world each year on just 200 acres of land,Cheaper (single dose of hepatitis-B vaccine would cost approximately 23 paise), grown locally using standard methods and do not require immense capital investment of pharmaceutical manufacturing facilities, exhibit good genetic stability. Do not require special storage condition. Since syringes and needles are not used chances of infection are also less. Fear of contamination with animal viruses - like the mad cow disease, which is a threat in vaccines manufactured from cultured mammalian cells - is eliminated, because plant viruses do not infect humans.
14 May 2011

AN OVERVIEW ON INTELLECTUAL PROPERTY RIGHTS IN PHARMACEUTICAL PATENT

About Author: A. A. Durgavale*, M. V. Mahale, S. R. Kane, Dr. S. K. Mohite, Dr. C. S. Magdum
Department of Quality Assurance,
Rajarambapu College Of Pharmacy,
Kasegaon, Tal - Walwa, Dist. - Sangli - 415404

Reference ID: PHARMATUTOR-ART-1058

Abstract
Intellectual Property (IP) refers to property created with the use of intellect. In other words, this refers to creation of mind. These are rights given to person over creation of their minds. They usually give the creator an exclusive right over use of his or her relation for certain period of time. Intellectual property differs from other form of properties as it does not have any physical shape and can be seen. Protection of Intellectual property is done by offering time limited rights to investor in form of patents.
Intellectual property laws vary from jurisdiction to jurisdiction, such that the acquisition, registration or enforcement of IP rights must be pursued or obtained separately in each territory of interest. However, these laws are becoming increasingly harmonized through the effects of international treaties such as the 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), while other treaties may facilitate registration in more than one jurisdiction at a time. Certain forms of IP rights do not require registration in order to be enforced. There are various forms of IP like Copyrights and related rights, Trade Marks, Geographical Indications, Industrial Designs, Lay out Designs of Integrated Circuits, Protection of Undisclosed Information (Trade Secrets), Patents, Plant varieties.
14 May 2011

An Emerging Complication of P. Vivax Malaria with Comparison of P. Falciparum Malaria

About Author: Dr.Ravindra Kembhavi, Asso. Professor PSM Department,
KEM hospital, Parel, Mumbai
Dr.Mahesh Ghadage, M.Sc pharmaceutical 2^nd year student,
KEM hospital, Parel, Mumbai

Reference ID: PHARMATUTOR-ART-1057

Abstract
Severe or complicated P. vivax malaria seldom results in pulmonary damage, and pulmonary complications are exceedingly rare while acute renal failure, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), hypoglycemia, coma, or epileptic seizures this are manifestations of severe or complicated P. falciparum malaria.
14 May 2011

Development and Validation of New Analytical Method for Estimation of Drotaverine in Bulk and Pharmaceutical Dosage Form by UV Spectrophotometry

About Author: Khuntia Bhabani S., M.Pharm., B.P.U.T.,
Department of Pharmaceutical Analysis and Quality assurance,
Royal College of Pharmacy and Health Sciences,
Berhampur, Odisha, India

Reference ID: PHARMATUTOR-ART-1056

Abstract
The present study includes a simple, sensitive and specific UV method development and validation for the quantitation of Drotaverine in bulk and pharmaceutical dosage form. The λmax was found to be 357nm by taking acetonitrile and water (50:50) as solvent. The validation of the proposed method was carried out as per ICH Guidelines. It was found that the drug was shown the linearity between the range 5-90µg/ml. The regression of the curve was y = 0.022x - 0.033. The developed method was found to be with %RSD 0.548499 for Drotaverine. The %RSD for intra-day and inter-day precision was lower than 2%. The percentage recovery values of pure drug from the reanalyzed solution of formulation were in between 95.68-99.5%. The ruggedness of the method was studied by taking in account of different analyst and by varying the temperature. Based on the performance characteristic the proposed UV method was found to suitable for the estimation of Drotaverine in bulk and pharmaceutical dosage form.