Articles

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
UPENDRA KUMAR SINGH*, Mr. Sammer Rastogi, Dr. Manish Kumar Yadav
^*MASTER OF PHARMACY in QUALITY ASSURANCE
School of Pharmacy, Lloyd Institute of Management and Technology
Uttar Pradesh, India
* upendra.singh81@gmail.com

ABSTRACT Quality Risk Management (QRM) is a key component for access the product quality. For any pharmaceutical product, Quality Risk Management shall be applied to aim that raising the level of protection for the patient by the reduction of the risk to which that patient is exposed at the time he /she receives a drug product. This general objective can only be achieved by implemented policy of Quality Risk Management (QRM) on the product and process design and its lifecycle. The concept of risk management was first applied in the financial and insurance sectors. This concept was systematically transferred and applied in the pharmaceutical industries in 2005 with the International Conference on Harmonization (ICH) and its publication of the ICH guideline Q9 on “Quality Risk Management”. The European Commission added this guideline as Annex 20 to the EU GMP guide in March 2008. This research was explored the risk identification, risk assessment and development scientific risk control measures during transportation of API from API manufacturing site to user site (formulation plant).

[adsense:336x280:8701650588]

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
M. Manasa Rekha1*, T.Mubeena2,
1*,2 Doctor of pharmacy,
Department of Pharmacy Practice,
Annamacharya college of Pharmacy,
Rajampet, Y.S.R kadapa district, Andhra Pradesh,  India.
* manasarekharoyal@gmail.com

ABSTRACT:
The area of the pharmacy concerned with science and practice of rational usage of the drugs. The clinical pharmacist is the one of the member in the health care team. clinical pharmacists provide care to their patients and that this practice can occur in any practice setting. Drug Utilization Reviews (DUR), also referred to as Drug Utilization Evaluations (DUE) or Medication Utilization Evaluations (MUE), are defined as an authorized, structured, ongoing review of healthcare provider prescribing, pharmacist dispensing, and patient use of medication. DURs involve a comprehensive review of patients' prescription and medication data before, during, and after dispensing to ensure appropriate medication decision making and positive patient outcomes.

{ DOWNLOAD AS PDF }

About Authors:
*Dilipkumar.J.P, Agliandeshwari.D
Rajiv Gandhi University of Health Sciences
Bangalore, India
*dilipkumar9447@gmail.com

INTRODUCTION
Natural products, especially those derived from plants, have been used to help mankind sustain its health since the dawn of medicine. Over the past century, the phytochemicals in plants have been a pivotal pipeline for pharmaceutical discovery. The importance of the active ingredients of plants in agriculture and medicine has stimulated significant scientific interest in the biological activities of these substances1. Despite these studies, a restricted range of plant species has experienced detailed scientific inspection, and our knowledge is comparatively insufficient concerning their potential role in nature. Hence, the attainment of a reasonable perception of natural products necessitates comprehensive investigations on the biological activities of these plants and their key phytochemicals2. In a pharmaceutical landscape, plants with a long history of use in ethno medicine are a rich source of active phytoconstituents that provide medicinal or health benefits against various ailments and diseases. One such plant with extensive traditional use is Annona muricata. In this review, we describe the botany, distribution and ethnomedicinal uses of this plant, and we summarize the phytochemistry, biological activities and possible mechanisms of A. muricata bioactivities.

About Authors:
Deepak singh^1*, Arpit Dixit², Amir khan³, Vikas singh⁴, Abhishek sachan^4
1*Department of Clinical Research, Jamia Hamdard, Hamdard nagar, New Delhi-110062
²Business executive at Merck Pvt.ltd, Ghaziabad, India
³Business executive at Cipla Pvt.ltd, Lucknow, India
⁴Shri RLT Institute of Pharmaceutical Science & Technology, Etawah(UP), India
*deep_singh4u21@rediffmail.com

ABSTRACT:
The present investigations, which were primarily conducted with the aim of investigating some neuropharmacological activity of Polygonum glabrum (PG), i.e. PG has got anxiolytic activity when tested against open field exploratory behavior, where as elevated plus maze did not show any positive results. The action produced by PG was more than that of diazepam in open field exploratory behaviour. Observations confirms that PG possesses significant antidepressant activity. The observed antidepressant activity of PG was qualitatively comparable to that induced by Imipramine. Pentobarbitone induced hypnosis in mice was significant potentiated by PG.PG at 100 and 200mg/kg, reduced locomotor activity in rats.The PG seems to be little or no motor incoordination effect in mice when tested against rota-rod test.PG had significant analgesic activity which is both centrally and peripherally mediated, when tested against various analgesic models in rodents.The investigations indicates that PG has significant analgesic, anti-inflammatory, antidepressant and anxiolytic actions, some of these actions, including antidepressant and anxiolytic can be rationalized on the basis of the neurochemical data emanating from this study . The present study indicate that PG can be clinically useful not only in inflammation, pain and fever, and worm infestation but also in depression and anxiety. Clinical studies are required to confirm the above mentioned activities.

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
¹Veerendra Kr. Gautam*, ²Mohamad. Irfan
1Executive in Drug Regulatory Affairs Department; East African (India) Overseas
¹ 120 Suncity Business Tower,Sector-54, Gurgaon-122002 (Haryana).
²Research Associate; Jubilant Chemsys Ltd.
²D-12, Sector 59, Noida , Uttar Pradesh, India
¹dra.veerendra.gautam@gmail.com;
¹viren.gautam.dra@gmail.com ²mohd.irfan.ivar@gmail.com

Abstract : Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. There are basically two formats for dossier preparation i.e. ICH-CTD and ACTD. ICH-CTD followed by ICH countries as well as low economical or developing countries where as ACTD is followed by ASEAN countries. ACTD act as bridge between regulatory requirements of developed and developing countries. Also if both guidelines of CTD and ACTD can be harmonized then differences and variation between both guidelines can be minimized.

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
Suleman S. khoja * ¹, Sohil S. khoja ¹, Karim R. Panjwani¹,
Jagdish Ray ¹ , Parthkumar H. chauhan ^2
1 Resource person in Pharmaceutical Quality Assurance,
Audit and Compliance, Vapi .
² Resource person in Quality Assurance,
Navsari
^*premukhoja@gmail.com

ABSTRACT:
It has been always International Regulatory concern on Role and Responsibility of Pharmaceutical Higher Management in  this review article we have taken some of the concern and how responsible  leadership should ensure the support and commitment of staff at all levels and sites within the organization to the Pharmaceutical Quality System ,management review , Quality committee and to make a platform for leadership engagement, awareness and decision making around quality and process performance. Implement new controls as per GMP Guidelines to check impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry.

[adsense:336x280:8701650588]

ABOUT AUTHORS
M. Manasa Rekha*,
Department of Pharmacy Practice,
Annamacharya college of Pharmacy,
Rajampet, Andhra Pradesh,  India.
*manasarekharoyal@gmail.com

ABSTRACT:
The study aims to assess the role of clinical pharmacist in Improving the quality of life of HIV patients in an antiretroviral therapy wards of a teritary care teaching hospital

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
L Reddenna¹*, Dr. P. Venkatesh¹, K Siva Kumar², A Sai keshava Reddy²
1* Department of Pharmacy Practice,
Jagan’s College of Pharmacy,
Nellore, Andhra Pradesh, India
² Department of Pharmacy Practice,
Nirmala College of Pharmacy,
Kadapa, Andhra Pradesh, India
*reddennapharmd@gmail.com

ABSTRACT
Genotoxicity describes the possessions of chemical agents that damage the genetic information within a cell causing mutations, which may lead to cancer. Heritable changes can influence either somatic cells of the organism or germ cells to be passed on to future generations. As a result, many urbane techniques including Ames Assay, in vitro and in vivo Toxicology Tests, and Comet Assay have been developed to evaluate the chemicals probable to cause DNA damage that may lead to cancer. The genotoxic substances provoke damage to the genetic material in the cells through exchanges with the DNA sequence and structure. Genotoxicity testing is to resolve if a substrate will sway genetic material or may cause cancer. Genotoxic Chemotherapy is the treatment of cancer with the use of one or more genotoxic drugs. The treatment is traditionally part of standardized regime. By utilizing the destructive properties of genotoxins treatments aims to induce DNA damage into cancer cells.

{ DOWNLOAD AS PDF }

ABOUT AUTHOR
Dhrubo Jyoti Sen
Department of Pharmaceutical Chemistry,
Shri Sarvajanik Pharmacy College,
Mehsana, Gujarat, India
dhrubosen69@yahoo.com

ABSTRACT: Our goal is to perform in-vitro biotransformation of Prodrugs of ibuprofen+paracetamol, diclofenac sodium+paracetamol and ibuprofen+diclofenac sodium by acidic and alkaline hydrolysis of both ester (–COO–) and amide (–CONH–) linkages into free drugs and chromatographically separation of their Rt in HPLC. Since both ester (–COO–) and amide (–CONH–) linkages are susceptible for hydrolysis in both acidic pH (gastric pH) and basic pH (intestinal pH) to produce parent drug ibuprofen, diclofenac and paracetamol by biotransformation in in-vivo; so it will be implemented as a Prodrug which can show prolong action on pain and fever after getting release into free parent drug by biotransformation. The HPLC (High Performance Liquid Chromatography) study reports the retention time (Rt) and release kinetics of three Prodrugs by taking HPLC degradation datas of three samples of Prodrugs and individual HPLC datas of parent drugs separately to compare the Rt value of release of three drugs from Prodrugs in both acidic and alkaline pH. Prodrug–A (logP=4.56) releases Ibuprofen & Paracetamol, Prodrug–B (logP=4.90) releases Diclofenac & Paracetamol and Prodrug–C (logP=6.13) releases Ibuprofen & Diclofenac. This is a comparison study of drug release in in-vitro gastric as well as intestinal pH focusing on in-vivo biotransformation.  Keywords: Prodrug-A/Prodrug-B/Prodrug-C, Ibuprofen, Paracetamol, Diclofenac sodium, Molecular weight, logP, UV λmax, IR, Mobile phase, TLC-Rf value, HPLC-Rt value, LOD, LOC