Articles

CHALLENGES ENCOUNTERED BY PHARMA PROJECT MANAGER

ABOUT AUTHOR
Purva Gupta.
IIHMR, New Delhi.
purvagupta456@gmail.com

New Domain: This problem arises when organisation has not handled similar project earlier and stake holders have no prior experience on the project.

New Technology / Challenging Technology: Selected Project involves use of new technology or new equipment or specially trained staff may pose delay in completion of task, thereby project.

A REVIEW ON LYOPHILIZATION: A TECHNIQUE TO IMPROVE STABILITY OF HYGROSCOPIC, THERMOLABILE SUBSTANCES

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ABOUT AUTHORS
SHIVANAND *, SAYANTAN MUKHOPADHAYAY
Division of Pharmaceutical Sciences S.G.R.R.I.T.S
Dehradun, Uttarakhand  248001, India.
*shiva3671@gmail.com

ABSTRACT:
The active pharmaceutical ingredient that is thermolabile and moisture sensitive in nature generally degraded in atmospheric condition and thus have reduced stability and self-life. Lyophilization is one of those techniques which is utilized effectively to improve such critical condition. It is the one of the emerging technology in themodern era, which is effectively involved in the preparation of several antibiotics (e.g., chloramphenicol, doxycycline) and anti-cancer drugs (e.g., doxorubicin, epirubicin). This technique effectively utilized the phenomenon of sublimation to obtained primary dried product followed by removal of excess amount of moisture by modulation of heat. This technique not only improved self-life of thedrug but also provides fast reconstitution and reduced the cost of storage and shipping. Inthis review article principle behind lyophilization, steps involved, formulation aspects, theimportance of lyophilization and detection of the end point in lyophilization along with recent advancementwas explained.

AN APPROVAL TO MANUFACTURE AND SALE THE COPY OF INNOVATOR PRODUCT IN THE US MARKET

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ABOUT AUTHORS
MUNISH THAKUR*,  Dr. ANUPAMA SETIA, Ms. NEETU.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT &
 DRUG REGULATORY AFFAIRS,
JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA).
munish.thakur98@gmail.com

ABSTRACT
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follows cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures. A drug is not permitted for sale until the marketing application for the new drug has been reviewed and approved by regulatory authorities. Extensive dossiers are provided to the authorities to demonstrate the safety, potency, efficacy and purity of the drug. After the drug has been approved and marketed, there is continuous monitoring of the safety and performance of the drug to ensure that it is prescribed correctly and adverse events (side effects) are investigated. The United States Food and Drugs Administration (FDA) has one of the most comprehensive and transparent regulatory systems in the world. In US Common Technical Document (CTD) format and most recently its electronic version-the electronic Common Technical Document (eCTD) format is used for submission of dossiers. Inclusion of a paragraph IV certification permits the Applicant to file its ANDA 4 years after the approval of a new chemical entity that is 1 year before the actual expiry of the 5 years exclusivity. In case patent exists that claims the drug, drug product, or method of use, the applicant is requested to file a patent certification with regards to the patent status. The different types of patent certifications are discussed. This project work elucidates US FDA’s previous interpretations of the statute regarding 180 days exclusivity and latest amendments in the current guidance. Information considered helpful in the compilation of different CTD modules 1, 2, 3, and 5 is discussed. Electronic submission in eCTD format is outlined.

PHARMACOLOGICAL SCREENING OF ANTI-ASTHMATIC ACTIVITY OF ETHANOLIC EXTRACT OF CALOTROPIS GIGENTEA LEAVES

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ABOUT AUTHORS
Khadar Shaik*, Shailaja Ande, Ravindrachary Dharmoji, Sowmya Ragini Yelwarthi, Anjum, Nisa Firdouse
Gyana Jyothi College of Pharmacy,Uppal, Hyderabad-98, Telangana, India
* khadarshaik41@gmail.com

ABSTRACT: 
Calotropis gigantea Linn., (Asclepiadaceae) a widely growing plant has been reported to possess number of medicinal properties. It has been reported as a traditional folk medicine for a variety of ailments. The calotropis leaves also possess anti-diabetic activity. The present study deals with the effect of ethanolic extract of leaves of calotropis gigantea by using in vivo models. The study shows that the extract is effective against histamine induced bronchial muscle contractions in guinea pigs. Animal study involves the use of ethanolic extract of leaves that shows action against histamine induced broncho- constriction by using histamine chamber. These studies showed significant protection at lower doses while further increase in dose showed increased activity. The results of these studies indicated usefulness of ethanolic extract of Calotropis gigantea in asthma.

HUMAN GENOME SCIENCE: A NEW FACE OF PHARMACEUTICAL SCIENCE: A REVIEW

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ABOUT AUTHORS
Tahseen Sameena*1, Prathima Patil1, S.P.Sethy*1
1Department Of Pharmaceutics.
Azad College of Pharmacy
Moinabad-Chilkur Road , Hyderabad- India
* tahseensameena1992@gmail.com

ABSTRACT: -
The Human Genome Project (HGP) refers to the international 13‐year effort, formally begun in October 1990 and completed in 2003, to discover all the estimated 20,000–25,000 human genes and make them accessible for further biological study. Another goal of this project was to determine the complete sequence of the 3 billion DNA subunits (bases in the human genome). As part of the HGP, parallel studies were carried out on selected model organisms such as the bacterium E.coli and the mouse to help develop the technology and interpret human gene function. The DOE Human Genome Program and the U.S National institute of Health (NIH) National Human Genome Research Institute (NHGRI) together sponsored the U.S.Human Genome Project.”

DENDRIMERS: A NOVEL CARRIER FOR DRUG DELIVERY SYSTEM

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ABOUT AUTHORS
Pandey Noopur*, Mahara Kamal
Department of Pharmaceutics
Global Institute of Pharmaceutical Education and Research,
Kashipur, Dehradun,
Himachal Pradesh, India
* noopurpandey56@gmail.com

ABSTRACT
Dendrimers are macromolecules having highly branched, 3 D structure, nano scale architecture with monodispersity and high functionality. These properties make it attractive candidates as unique and optimum drug carriers for controlled release or targeted delivery. Dendrimer is a smart polymer and as a result of their behavior dendrimers are suitable for a wide range of biomedical and industrial applications and in medical applications such as drug delivery, tumor therapy, diagnostics etc. The field of dendrimers has recently emerged as the most commercially viable technology of this century because of its wide ranging potential applications in many fields such as: healthcare, electronics, photonics, biotechnology, pharmaceuticals, drug delivery, catalysis and nanotechnologies. The review aims mainly on the introduction, objectives, properties, synthesis and applications, in future aspects of dendrimers. Dendrimers help in achieving increased bioavailability, sustained, controlled and targeted release of drug. Thus present review focuses on the fundamentals of dendrimers and their use as drug delivery agents in treatment of disorders.

QUALITY RISK MANAGEMENT (QRM) OF ACTIVE PHARMACEUTICAL INGREDIENTS DURING TRANSPORTATION BY USING FMEA TOOLS AND METHODOLOGY

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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).

A STUDY ON ROLE OF DOCTOR OF PHARMACY IN DRUG UTILIZATION EVALUATION PATTERN ANALYSIS IN INPATIENT UNITS AND REPORTING ITS COMORBIDITIES IN A TERTIARY CARE TEACHING HOSPITAL

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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.

PREPARATION & EVALUATION OF ANNONA MURICATA EXTRACT AGAINST CANCER CELLS WITH MODIFIED RELEASE

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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.

ANTIDEPRESSANT ACTIVITY ON LEAVES OF POLYGONUM GLABRUM WILLD IN EXPERIMENTAL ANIMAL

About Authors:
Deepak singh1*, Arpit Dixit2, Amir khan3, Vikas singh4, Abhishek sachan4
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.

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