Miscellaneous Articles

QUALITY PHILOSOPHY FOR PHARMACEUTICAL CONTAINERS AND CLOSURES

About Authors:
*Tarun Patel, Prof. Dr. Vipin Kukkar, Arshad hala, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*tarunpatel35@gmail.com

ABSTRACTS:
In pharma industry containers and closures play important role for improving quality of pharma products in market. For improving quality of containers and closures there are different types of raw materials are used like glass, plastic, rubber, metal etc. Out of that all raw materials in manufacturing of containers and closures widely use is plastic because of its less interaction with product as compare to other materials. In this review articles we discuss about quality of containers and closures.

PROBLEM: ENVIRONMENTAL POLLUTION AND GLOBAL WARMING IDEA TO IMPLEMENT GREENERY IN INDIA

The main problem which we are facing is the Global warming because of the polluted atmosphere. My idea can reduce the global warming and can bring back the polluted free environment

MAIN OBJECTIVE:
Converting the brown economy to green economy can be done very easily and fastly only by the Indian youth by starting an effective campaign by name “earth warriors” or some other easy feasible name so that everyone in India can understand the theme of the program easily unlike the other programs that we had earlier like great power race or carbon credit race etc., which takes time for the people to understand the theme of the campaign.

CONTRACT MANUFACTURING AND THEIR AUDITING

About Authors:
Arshad Hala*, Prof. Rajesh Dholpuria, Nilesh Sovasia
1Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*Arshad_hala@yahoo.com

1. INTRODUCTION:-
1.1. Origin:-

Contract manufacturing is defined as the manufacture (or partial manufacturer) of a product to the order of one person or organization (the contract giver or customer) by another independent person or organization (contract acceptor or principle manufacturer). Manufacture in this context is identified as the act of processing or packaging a medicinal product or device to a given specification.(Shah, D.H., 2000)

Contract manufacturing should be consideration as an extension of the principal manufacturer’s operation. Consequently the principal manufacturer should require the same standards of good manufacturing practices (GMP) for a contractor’s operation as he would his own. In addition, the customer must ensure that the principle manufacturer holds the relevant legal authorizations for the work to be carried out.(Shah, D.H., 2000)

The responsibility and activities undertaken by each party need to be clearly stated in a formal agreement, separate from but additional to the legal business contract formed by the placement of an order. Commercial matters need to be appreciated as being distinct from technical matter and need to be detailed separately with due consideration for compliance with local legislation.(Shah, D.H., 2000)

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.

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

About Authors:
Krunal Parikh1*, 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 1st 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.

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.

ROLE OF PURPLE CORN IN TREATMENT OF TYPE 2 DIABETES AND KIDNEY DISEASE: A THERAPEUTIC REVIEW

About Authors:
Mr. Satyanand Tyagi
President, Tyagi Pharmacy Association & Scientific Writer,
Chattarpur, New Delhi, India.
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 50 Publications (42 Review Articles and 08 Research Articles of Pharmaceutical, Medicinal and Clinical Importance, published in standard and reputed National and International Pharmacy journals; Out of 50 publications, 11 are International Publications).
sntyagi9@yahoo.com,
+91-9871111375 / 9582025220

ABSTRACT:
Diabetic nephropathy is one of the most serious complications related to diabetes, often leading to end-stage kidney disease. Purple corn grown in Peru and Chile is a relative of blue corn, which is readily available in the U.S. The maize is rich in anthocyanins (also known as flavonoids), which are reported to have anti-diabetic properties. Scientists from the Department of Food and Nutrition and Department of Biochemistry at Hallym University in Korea investigated the cellular and molecular activity of purple corn anthocyanins (PCA) to determine whether and how it affects the development of diabetic nephropathy (DN). Their findings suggest that PCA inhibits multiple pathways involved in the development of DN, which may help in developing therapies aimed at type 2 diabetes and kidney disease. The aim of present article is to provide in depth knowledge about Purple Corn, their clinical and biological utility as well as their role in treatments of type 2 diabetes and kidney disease. An attempt is also made to focus on compounds found in purple corn which may aid in developing future treatments for type 2 Diabetes as well as kidney disease.

NANOTECHNOLOGY USED IN CANCER TREATMENT- A REVIEW

About Author:
Himani Sharma
B.Pharm, RGTU
shimani53@gmail.com

ABSTRACT
Nanotechnology provide innovative tools that shed greater light on life cycle of normal cells and the point at which molecular processes and changes within cells become correlated with development of cancer. It should be possible to obtain large amount of information from a small source. They aid in analysis of parameters such as cellular mechanics, morphology and cytoskeleton which has been hard to achieve using conventional technology. Nano devices can detect cancer cells, identify cancer signatures and provide targeted delivery of anti cancer therapeutics and contrast agents to tumour cells. Nanotechnology is potential tool that could help detect the molecular changes and assist in focusing on preventive efforts. Nanotechnologies for medical applications have been maturing. Several therapeutic formulations entered clinical trials and are expected to have an impact on how cancer treatment is done in the future.

PROCEDURE TO OBTAIN PATENT IN INDIA

About Authors:
Arshad Hala*1, Prof. Rajesh Dholpuria1, Nilesh sovasia1
1 Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*Arshad_hala@yahoo.com

ABSTRACT:
A patent is one of the forms of intellectual property. The object of patent law is to encourage scientific research, new technology and industrial progress. The grant of exclusive privilege to own, use or sell the method or product patented for a limited period, stimulates new inventions of commercial utility. The price of the grant of the monopoly is the disclosure of the invention at the patent office, which after the expiry of the period of monopoly, passes into public domain. An invention which must be new and useful. It must have novelty and utility. The patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonable practicable without undue delay. So true inventor required to know how to get patent in india and other countries through his self or legal representative. Without patent no one use, sell, and research on invention.This review looks into procedure to obtain patent in india.

CHRONOPHARMACOKINETICS: THE CIRCADIAN RHYTHM OF DRUGS AND ITS IMPLICATIONS

About Authors:
N Allamneni*, CH Ajay Babu, AVS Madhulatha, C Anusha, P Sowjanya, BV Komali, M Kalyani, Syed M
*Department of Pharmaceutical Technology,
Narasaraopeta Institute of Pharmaceutical Sciences,
Narasaraopeta, Guntur, India.
*yaswanthallamneni@gmail.com

ABSTRACT
Chronopharmacokinetics involves the study of temporal changes in drug absorption, distribution, metabolism and excretion with respect to time of administration. Drug Absorption, distribution, metabolism and elimination are influenced by many different physiological functions of the body, which may vary, with time of day. Thus, the pharmacokinetic parameters characterizing these different steps, conventionally considered to be constant in time, depend on the moment of drug administration. Chronokinetic studies have been reported for many drugs in an attempt to explain chronopharmacodynamic phenomena and demonstrate that the time of administration is a possible factor of variation in the kinetics of a drug. However, the time of day has to be regarded as an additional variable influencing the kinetics of a drug since many drugs are affected by time of administration and the activity or rest period of the human or animal.

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