Articles

31 October 2012

QUALITY MANAGEMENT OF WASTE AND SCRAP DISPOSAL

About Authors:
Sahil Jasuja¹*, Mahesh Kumar Kataria¹
1 Department of Quality Assurance,
Seth G.L. Bihani S.D. College of Technical education (Institute of Pharmaceutical Sciences & Drug Research),
Sri Ganganagar, (Raj.), India.
*sahiljasuja@rediffmail.com

ABSTRACT
Regulatory involvement and environmental concerns are causing pharmacists to take a closer look at how their organizations are managing pharmaceutical waste. Each organization should evaluate its current waste management practices in comparison with state regulatory guidelines. Organizations must then develop a comprehensive plan for full compliance through segregation of waste into the appropriate waste streams. The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the country is raising concerns about the potentially adverse environmental consequences of these contaminants. Pharmaceutical waste is not one single waste stream, but many distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceuticals. Pharmaceutical waste is potentially generated through a wide variety of activities in a health care facility, including but not limited to intravenous (IV) preparation, general compounding, spills/breakage, partially used vials, syringes, and IVs, discontinued, unused preparations, unused unit dose repacks, patients’ personal medications and outdated pharmaceuticals. The consistent increase in the use of potent pharmaceuticals, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated.
31 October 2012

ANALYSIS OF SAMPLES BY TECHNIQUE OF GAS CHROMATOGRAPHY

About Authors:
Kapil Sharma*, Priyanka sharma
*Yaresun Pharmaceutical Pvt Ltd, Jaipur, India
*pharma_kapil@rediffmail.com

INTRODUCTION
Gas chromatography is a widely used technique for the separation of gaseous and volatile sub which are difficult to separate.The primary limit of s technique is that sample must be capable of being volatilized without undergoing decomposition because of this this technique is replaced by H.P.L.C.It is similar to column chromatography except that the gas is used as the mobile phase instead of the liquid.Here gas as a mobile phase or moving phase is passed through a column a column containing liquid adsorbent coated on inert solid support ,thus the adsorption or partition is possible.Gas solid chromatography(G.S.C) based upon the selective adsorption on solid,so the component of mixture distributes them selves between the gas phase and adsorbent and the separation is due to adsorptive properties.where as Gas liquid chromatography (G.L.C) is based upon partition between Gas and immobile liquid coated on solid,.so the component of mixture distributes them selves between the gas phase and liquid adsorbent coated on solid and the separation is due to partition properties¹.

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30 October 2012

Radio Immunoassay of Drugs and Hormones

About Authors:
Dhiren Shah
m.pharmacy
Seth G.L.Bihani S.D.College of Pharmacy, R.U.H.S.
Sri Ganganagar, Rajasthan, INDIA
dhiren.pharmacist@gmail.com

Abstract
A method has been developed for immobilisation of antisera on fresh plastic tubes through an immunochemical bridge. This type of immobilisation has been shown to be more consistent than direct adsorption on plastic. Such immunochemically coated antisera on plastic tube has been used in the development of a noncentrifugation radioimmunoassay. This assay system has been found to be technically as sound as the conventional method.
30 October 2012

INTRODUCTION TO STEM CELL CRYOPRESERVATION – A NEWER PHENOMENON OF ENSURING THE LONGEVITY OF CHILD HEALTH: A CLINICAL REVIEW

About Authors:
Mr. Satyanand Tyagi*, Raghvendra¹, Amlan Mishra², Patel Chirag J³, Asheesh Singh⁴
*President, Tyagi Pharmacy Association & Scientific Writer (pharmacy), Chattarpur, New Delhi, India-110074.
Prof. Satyanand Tyagi is a life time member of various pharmacy professional bodies like IPA, APTI and IPGA. He has published various research papers and review articles. His academic works include 51 Publications (43 Review Articles and 08 Research Articles of Pharmaceutical, Medicinal and Clinical Importance, published in standard and reputed National and International Pharmacy journals; Out of 51 publications, 11 are International Publications).
He has published his papers almost in different specialization of Pharmacy field...His research topics of interest are neurodegenerative disorders, diabetes mellitus, cancer, rare genetic disorders as well as epilepsy. ¹Department of Pharmaceutics, Aligarh College of Pharmacy, Aligarh, U.P, India-202001.
²Department of Pharmacology, Smt. Vidyawati College of Pharmacy, Jhansi, U.P, India-284128.
³Department of Pharmaceutics, Maharishi Arvind Institute of Pharmacy, Mansarovar, Jaipur, Rajasthan, India-302020.
⁴Research Associate, Center for Research and Development, Ipca Laboratories Ltd Ratlam, Madhya Pradesh, India-457114.
*sntyagi9@yahoo.com, +91-9871111375 / 9582025220

ABSTRACT:
The umbilical blood cord being rich in stem cells needs to be preserved by means of a new technique called cryopreservation. The Process whereby whole tissues or cells are preserved by cooling at very low temperatures is known as Cryopreservation. Stem cell cryopreservation is a relatively new phenomenon; it is one way of ensuring the longevity of child’s health. This is done by banking the baby’s umbilical cord blood affluent with stem cells. Stem cells are important as they can grow into tissues, even organs like the heart or liver. What is more, they have the awesome potential to revamp damaged tissues.

Till date, over seventy diseases have been successfully treated with the help of stem cell stored in the cord blood. Research on stem cells has, by no means, abated. Scientists realizing their potential and worth are carrying out intensive research on their uses as well as ways preservation. Before preserving stem cells, a biological test is carried out to eschew the possibility of deadly diseases like various types of Hepatitis or HIV. That done, the cord blood cells are now stored by means of the technique under discussion- Cryopreservation. This technique involves adding a cryopreservant that lets the blood freeze gradually. The blood is frozen to sub-zero degree temperatures so that biochemical reactions or any other dangerous biological that could cause cell death may be arrested. Typically, the cells are stored at temperatures as low as -196, – 156, or – 120 degrees centigrade. Freezing stem cells through cryopreservation at such low temperatures is supposed to ensure their longevity. Let it be known, however, that scientists are still divided over the optimum temperatures as well as the efficacy of the cryopreservation technique itself. The aim of present article is to provide in depth knowledge about this technique of preserving stem cells of child i.e. the technique so called “Cryopreservation”. An attempt is also made to focus how this technique ensures the longevity of child’s health.
29 October 2012

AMMENDMENTS IN PATENT ACT- 1999,2002 AND 2005- OVERVIEW AND COMPARISON

About Authors:
Krunal Parikh^1*, Mr. Maheshkumar Kataria²
(assistant professor, Department of pharmaceutics)
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTARCT :
The word Patent originated from the Latin Word "Patene" which means 'to open'. A patent is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention.

Under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any inventions, in all fields of technology, and the term of protection available should be the minimum twenty years. Different types of patents may have varying patent terms(i.e., durations).After 1972 The Act remained in force for about 24 years without any change till December 1994. An ordinance effecting certain changes in the Act was issued on 31 st December 1994, which ceased to operate after six months. Subsequently, another ordinance was issued in 1999. This ordinance was subsequently replaced by the Patents (Amendment) Act, 1999 that was brought into force retrospectively from 1^st January, 1995. The amended Act provided for filing of applications for product patents in the areas of drugs, pharmaceuticals and agro chemicals though such patents were not allowed. However, such applications were to be examined only after 31-12-2004. Meanwhile, the applicants could be allowed Exclusive Marketing Rights (EMR) to sell or distribute these products in India, subject to full filment of certain conditions.
29 October 2012

DEVELOPMENT AND VALIDATION OF QUETIAPINE BY HPTLC METHOD

About Author:
Gautam Kumar
SRM college of pharmacy,SRM University
Chennai 600 033.
gautamsinghsrmcp@gmail.com

Abstract
The aim of the present work is to develop validated HPTLC method which determines stress stability and concentration of Quetiapine and its formulation as per ICH guidelines. Separation was performed using Camag Linomat V semi Automated sample applicator with TLC Scanner III. HPTLC analytical measurement and separation were performed using Stationary Phase consisting of TLC plates (Merck) pre coated with silica gel 60F254 on Aluminum Sheets was used. Mobile phase comprising of Methanol: Toluene (7:3 v/v) was used. All the system suitability parameter was found within the range. Area under curve was measured at 235nm. The method was extensively validated for specificity, linearity, accuracy, precision, recovery, limit of quantitation and detection. The proposed method can be used for routine analysis of Quetiapine in quality control laboratories.
28 October 2012

EXTENDED RELEASE DRUG DELIVERY SYSTEM: A REVIEW

About Authors:
Mahek Goel*, Minakshi Marwaha
Shri Baba Mast Nath Institute of Pharmaceutical Sciences and Research, Asthal
Bohar, Rohtak-124001
*mahekgoel10@gmail.com

Abstract
Oral drug delivery system is the largest and the oldest segment of the total drug delivery market. As the drug which are presently available in the market suffered from the problem of resistance due to their irrational use as well as very few drugs are coming out of research and development, so there is need of the development of oral controlled drug delivery system (CDDS). Controlled release dosage forms are designed in such a way so that to maintain a constant level of drug for a specific period of time with minimum side effects. CDDS optimizes the biopharmaceutical, pharmacokinetic and pharmacodynamic properties in such a way that its dosing frequency is reduced to an extent that once daily administration is sufficient to maintain the desired therapeutic level of drug with reduction in side effects in shorter possible time to assure greater patient compliance. This review describes various advantages, disadvantages, types of modified release, desired characteristics, approaches and evaluation tests for controlled release dosage forms.
28 October 2012

REGISTRATION DOSSIER OF PHARMACEUTICALS

About Authors:
Apeksha Gupta
Maharshi Dayanand University,
Rohtak, India.
apekshagupta87@gmail.com

ABSTRACT
The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical) and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval or the “Registration” “Marketing Authorization” or the “Product Licensing”.
“Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing.

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28 October 2012

A REVIEW ON: AEGLE MARMELOS

About Authors:
Kishan Singh *, Krishn Kumar Agrawal
Institute of Pharmaceutical Research GLA University,
Mathura-281403 (U.P.) India.
*kishan.singh575@gmail.com

ABSTRACT
Herbal drugs are traditionally used in various parts of the world to cure different diseases. The Ayurvedic and Siddha medical systems are very famous medical practices in Indian traditional medicines. Over the last few ,researcher have aimed at identifying and validation plant derived substance for the treatment of various disease .similarly it has been already proved that various parts of plants such as leaf, fruits seeds etc.provide heath and nutrition promoting compounds traditional used against various disease. Aegle marmelos have been used in ethno medicine to exploit its’ medicinal properties including astringent, antidiarrheal antidysentric, demulcent, antipyretic, and anti-inflammatory activities. The present review aims to complete medicinal values of Aegle marmelos generated through the research activity using modern scientific approaches and innovative scientific tools.
26 October 2012

FORMULATION AND EVALUATION OF AMOXICILLIN TRIHYDRATE MODIFIED RELEASE DOSAGE FORMS

About Author:
^*1Patel Dimpalben Girishkumar, ²Mr.K.H.Shah, ³ Rohit K Patel, ³Yatish Shukla, ³Modi B, ³Nilesh Patel
¹ Dharmaj Degree Pharmacy College,
Dist- Anand, Dharmaj -388430, Gujarat
²Professor, IPCPRC, Dharmaj, Gujarat
³ KAPTAB Pharmaceuticals
*dimplepatel70@gmail.com

Abstract
The aim of the current investigation is to design oral once daily modified release dosage forms of amoxicillin trihydrate for treatment of pharyngitis/tonsilitis, which release the drug for 24 hours and match with theoretical drug release profile. The tablets and capsules were prepared by the different method using different polymers in different concentrations. The interference of the polymers was ruled out by FT-IR spectroscopy studies. The powder-blends of tablets and drug were evaluated for their physical properties like angle of repose, bulk density, compressibility index, and Hausner ratio and found to be satisfactory. The manufactured tablets were evaluated for in process and finished product quality control tests including appearance, thickness, weight variation, hardness, friability, drug content, and in vitro drug release. All formulations showed appearance, thickness, weight variation, hardness, friability and drug content in specified limit. All formulations showed acceptable pharmacotechnical properties and complied with in-house specifications for tested parameters. The results of dissolution studies indicated that formulation containing 50% ethyl cellulose and 50% methocel was the most successful formulation which was evidenced by similarity (f2) and dissimilarity (f1) factors. The formulated amoxicillin trihydrate tablets followed zero order release kinetics and Higuchi diffusion was the dominant mechanism of drug release, resulting in regulated and complete release within 24 hours. Formulations were subjected to short term stability studies as per ICH guidelines and were found stable. Capsule formulations 16 were evaluated for weight uniformity, drug content and in vitro drug release. The results of dissolution studies indicated that drug release from capsule not extend up to 24hrs. All formulations of capsule failed in in-vitro drug release test. In comparison of tablet and capsule formulations, tablet found to be successful dosage form.