Review Articles

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ABOUT AUTHORS
G. TARUN KUMAR REDDY *¹, G. NAVEEN KUMAR REDDY ^2
1 Department of Pharmaceutics and Drug regulatory affairs,
Annamacharya college of Pharmacy,
Rajampet, Kadapa, Andhra Pradesh, India.
² Department of Pharmaceutical analysis,
Sri Padmavathi school of Pharmacy,
Chittoor, Andhra Pradesh, India.
*gtarunkreddy@gmail.com

ABSTRACT: 
The regulatory bodies are being established in various pharmaceutical industries across the globe which plays a vital role to meet the requirements of legal procedures related to drug development process in a country. The pharmaceutical industry is considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Countries possess their own regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. This article describes about the development of the drugs as it is a cumbersome process which includes several months of time, volunteers, and a huge finical investment majorly through the funding process, so it is strictly regulated as per the norms and regulations as given by those individual countries to carry out the drug development which were generally governed by the Drug Regulatory Affairs Personals.

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*P.Dhaneshwar¹, P.Stephen², A.N.RAJALAKSHMI¹
1* Department of Pharmaceutics,
College of pharmacy,
Mother Theresa Post Graduate & Research Institute Of Health Sciences, Puducherry, India
² Sai mirra innopharm pvt ltd,
Ambattur, Chennai, India
*dhanesh7pharma@gmail.com

Drug absorption in the gastrointestinal tract is a highly variable process and prolonging gastric retention of the dosage form extends the time for drug absorption. Novel drug delivery system overcomes the physiological problems of short gastric retention through various approaches including floating drug delivery systems (FDDS), these systems float due to bulk density less than gastric fluids and so, remain buoyant in the stomach for a prolonged period of time, releases the drug slowly at the desired rate from the system and increase the bioavailability of narrow absorption window drugs. This review entitles the applications of sustained release effervescent floating bilayer tablets, suitable for sustained release of those drugs incompatible with floating constituents over an extended period of time for better patient compliance and acceptability. The purpose of this paper is to review the principle of sustained release effervescent floating drug delivery system, current technology used in the development of same as well as summarizes the applications, advantages, methodology, evaluation methods and future potential for sustained release effervescent floating bilayer tablets

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*¹Bhuyan Nadugopal, ¹Swain Sabhya Sampada, ¹Ojha Sudip Kumar, ²Meher Chaitanya Prasad
¹Gayatri Institute of Science and Technology, Gunupur, Rayagada,765022, Odisha
² The Pharmaceutical College,Tingipali,Barapali,Dist-Bargarh,Odisha
*nadugopal.1997@gmail.com

ABSTRACT:- The radioactive agents used in the nuclear medical field are called radiopharmaceuticals. A radiopharmaceutical is a drug, that contains a radionuclide in the form of a simple salt or a complex.  It may exist as a solid, liquid, gas or a pseudo gas. It is used in nuclear medicine for the diagnosis and therapy of many diseases. The chemical and physical identity and a form of a radiopharmaceutical are very important because in each case, once administered the radiopharmaceutical is intended to target certain tissues, binding sites, biochemical pathways. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. Many of the radiopharmaceuticals used for the diagnostic purpose, like C14 for pancreatic study and breath test, Cr51used for red cell volume and GFR measurement, Co57 used for gastrointestinal absorption. In radiopharmaceuticals, technetium has a versatile activity due to its large usage.  This review article describes the production of radiopharmaceutical, types of radiation source used in healthcare, diagnostic imaging technique, therapeutic application as well as advantage and disadvantage of radiopharmaceuticals or radiation therapy. The main aim of this review article is to describe how radiation source or radiopharmaceuticals affect the healthcare system.

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About Authors:
Utkranti D. Aher, *Tushar T. Shelke, Ekta P. Patel
JSPM’S Charak College of Pharmacy and Research,
Wagholi,  Pune
*tts.ccopr@gmail.com

ABSTRACT
Now a day’s medication systems that need frequent dosing are always with problems. So there is thrust in the area of pharmaceutical research to develop novel formulations, which will enhance the therapeutic efficacy of the existing drug. The goal of this study is to provide detailed and different techniques of pelletization such as powder layering, suspension and solution layering, globulation, freeze, extrusion - spheronization, cryopelletization etc. It has some merits, demerits and its characterization as a tool in the multipariculate drug delivery system.etc. It also gives brief idea about the evaluation of pellets and application of pelletization technique. Evaluation of quality of the pellets is discussed with reference to the size distribution, shape, surface morphology, specific surface area, friability and  tensile strength.

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Saptarshi Samajdar¹, Amiya Kr. Ghosh^2
1Centre for Pharmaceutical Sc. And Natural Products, Central University of Punjab
²Dept. of Pharmacy, Utkal University, Orissa
*saptarshisamajdar20@gmail.com

ABSTRACT: SesbaniaSesban Linn. (Family: Fabaceae) found all through the fields of India and ordinarily called as Jayanti. Herbals which shape a piece of our nourishment and give us an extra helpful impact are sought after and SesbaniaSesban Linn. is one of such plant. The plant has got great restorative significance. Blooms contain cyanidin and delphinidinglucosides, Pollen and dust tubes contain alphaketoglutaric, oxaloacetic and pyruvic acids. The leaves of Sesbania is additionally found to have hepatoprotective and powerful hostile to oxidant and against urolithiatic action. The ethanolic and fluid extraction of various parts of Sesbania. The present survey outlines the different pharmacological activities of Sesbaniasesban Linn.

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Gauri Nilewar*, P.B. Mute, P.P. Talhan, Shruti Thakre,
Dr. R.G. Bhoyar college of Pharmacy,
Wardha Maharashtra, India
*samvedna.nahatkar90@gmail.com

ABSTRACT
Nano capsules are vesicular systems in which the drug is confined to a cavity consisting of an inner liquid core surrounded by a polymeric membrane. Nano capsules having various advantages and disadvantages. Preparation of Nano capsules can be used as a two types of polymers 1) Natural polymers 2) Synthetic polymers. Nano capsules are prepared by different method those are a) Solvent evaporation b) Nano precipitation c) emulsification / Solvent diffusion d) Salting out e) Dialysis f) Super critical fluid technology. Different characterization and evaluation tests are performed to Nano capsules. Dispersed polymer nanocapsules can be used as nano-sized drug carriers to get controlled release as well as efficient drug targeting. Drug-loaded polymeric nanocapsules have showed possible applications in the field of drug delivery systems. Enormous research efforts have been performed in order to develop modern nano-particulate drug delivery systems. However, newly developed drug molecules with moderate biopharmaceutical profile are still missing. The entrapment of this drug molecule can protect them from the biological environment and facilitate their transport through biological barriers. Therefore nano-carriers especially nanocapsules (NC) can give the promise for therapeutic benefits in the field of drug delivery system. Nanocapsules, existing in miniscule size, range from 10 nm to 1000 nm. They consist of a liquid/solid core in which the drug is placed into a cavity, which is surrounded by a distinctive polymer membrane made up of natural or synthetic polymers. They have attracted great interest, because of the protective coating, which are usually pyrophoric and easily oxidized and delay the release of active ingredients.

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Nesar Ahmad*,Zafar Khan, Noorul Hasan, Abdul Basit, Seikh Zohrameena
Department of Pharmacology,
Faculty of Pharmacy,
Integral University, Lucknow, UP, India
*nesar50@gmail.com

ABSTRACT 
Stroke is a destructive experience which can result in permanent disability in brain. There is no permanent drug which can improve the blood flow at infracted area and also improve the neurological deficit. Due to the lack of treatments available for stroke, many researchers will investigate the suitable plants or drugs for the treatment of this disease. Numerous medicinal plants and herbal drugs are available to treat stroke, some of the plants are Ginkgo biloba, Fructus Chebulae, Pomegranate, Rosa laevigata, Garlic, Leonurus heterophyllus, Olive, Grape, Allium cepa, drugs such as Pravastatin, Senkyunolide I, Phloretin, Mgso4, HAMI 3379, Oleoylethanolamie, scopolamine and mecamylamine, Nitric Oxide, N-nitro-L-arginine methyl ester (L-NAME), 3,5,6,7,8,3’,4’-Heptamethoxy flavones, Rosiglitazone, Puerarin, the activity was estimated by parameters like superoxide dismutase (SOD) activity, Hemispheric swelling index (cerebral edema), H2O2 induced cell injury, OGD-R induced cell injury, superoxide dismutase and glutathione peroxidises, mitochondrial membrane potential, Western blotting assay, ROS scavenging assays, Superoxide anion  scavenging assay, Hydroxyl radical  scavenging assay, H2O2 scavenging assay, Singlet oxygen scavenging assay, Peroxyl radical scavenging assay, Peroxynitrite anion scavenging assay, myeloperoxidase (MPO) activity, blood–brain barrier integrity, cerebral infarct size, in Situ Apoptosis Detection, Western blotting, SOD, GSH, glutathione peroxidase, and MDA levels, Reverse transcription polymerase chain reaction (RT-PCR), Lactate dehydrogenase activity assay, Determination of caspase activity, acetylcholinesterase (AChE) activity, Determination of choline acetyltransferase activity (ChAT), Cell viability, Oxygen glucose deprivation/reperfusion assay, Flow cytometry, Immunohistochemistry.  The present review focused on different medicinal plants and drugs that have been tested in Stroke in animal models.

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ABOUT AUHTORS
Suleman S. khoja * 1, Sohil S khoja 1,Parthkumar H chauhan 2,Farhad S Khoja 3 ,Shamim S Khoja3.
1) Resource person in Pharmaceutical Quality Assurance, Audit and Compliance, Vapi -396191.
2) Resource person in Quality Assurance, Navsari
3) Registered Pharmacist ,Gujarat State Pharmacy council, Vapi -396191
*premukhoja@gmail.com

ABSTRACT:
Data integrity is fundamental in a pharmaceutical quality system which ensures the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), Arrangements shall be in place within an organisation with respect to people, systems and facilities that shall be  designed, operated and where appropriate adapted to support a working environment and  organisational culture that ensures data is complete consistent and accurate in all its forms, i.e. paper  and electronic record .When taken collectively these arrangements fulfil the concept of data governance. Regulatory bodies expect that data shall be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to detect and prevent data integrity issues. Industry should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and best business models. In recent year Regulatory observation has increasingly observed GMP violations involving data integrity risks during CGMP inspections. This is troublesome because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, Regulatory is concern with ability to protect the public health.

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Sunil Shastri*, Harsh Narang.
Seth G.L. Bihani S.D. College of Technical Education,
Sriganganagar, Rajasthan.
sunil11044@gmail.com

ABSTRACT
The Combinatorial Chemistry is a scientific method in which a very large number of chemical entities are synthesized by condensing a small number of chemical compounds together in all combinations defined by a small set of chemical reactions.
Combinatorial technologies provided a possibility to produce new compounds in practically unlimited number. New strategies and technologies have also been developed that made possible to screen very large number of compounds and to identify useful components of mixtures containing millions of different substances. Instead of preparing and examining a single compound, families of new substances are synthesized and screened. In addition, combinatorial thinking and practice proved to be useful in areas outside the pharmaceutical research Such as search for more effective catalysts and materials research. Combinatorial chemistry became an accepted new branch within chemistry.
The aim of this project is to provide a basic introduction to the field of combinatorial chemistry describing the development of major techniques and some applications.