Articles

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ABOUT AUTHORS
RATIKANTA SAHOO, PRATYUSH KUMAR DAS*
Centre for Biotechnology,
Siksha ‘O’ Anusandhan University,
Bhubaneswar, Odisha, India
pratyushdas@soauniversity.ac.in

ABSTRACT
Bromelain is a plant protease present in different parts of the pineapple [AnanasComosus (Linn.) Merr.]plant. It is an enzyme of high commercial interest which can be attributed to the wide therapeutic and industrial applications it possesses. As such efficient purification and recovery of the enzyme is utmost necessary on a large scale basis. The review highlights the numerous applications of the protease enzyme and further discusses the various purification techniques beginning from simpler ultrafiltration to the more complex and specific column chromatography that are being commonly employed nowadays. Effort has been made to compare the purification strategies extensively and suggest the best among the techniques which is cost-effective, has high output and can be used on a large scale production basis.

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Senthamil Selvan T *
Pharmaceutical Technical service department,
Mylan Laboratories Limited, Tamilnadu, India
Pharmtamil@gmail.com

ABSTRACT
Dementia is a chronic progressive disorder mainly causes the memory loss and cognitive dysfunction due to neurodegeneration. It is popularly known as Alzheimer disease. It is the fifth disorder leads to death. Those who are the people have crossed age 60 years risk chance of cause. Dementia the disorder is widely known as Alzheimer’s disease, senile dementia, vascular Dementia, Dementia with levy bodies, Parkinson’s disease, Frontotemporal dementia. By neurological examination like CT, MRI, and Spinal fluid analysis can occasionally be justified to confirm the dementia syndrome. For the AD the treatment are broadly takes place as two types, one is cognitive symptoms treatment, another Non- cognitive symptoms treatment. In that case for cognitive sign treatment cholinesterase inhibitors (such as Donepezil, rivastigmine), NMDA receptor inhibitors (Memantine) are used. Anti-psychotics’, Anti-depressant category drugs are used for Non-cognitive symptoms treatment.

ABOUT AUTHORS
Piyush Tripathi*,  Abhishek Arora
GMSCL,
GUJARAT(INDIA)
^*piyushtripathi1992@rediffmail.com

Drug addiction is a serious problem in one country that is known for its culture, traditions & social values all over the world. The country where people commit suicide either because of love affairs or due to drug addiction related issues. Undoubtedly, this writing is talking about India.

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Ms. NEETU*, Dr. ANUPAMA SETIA, Mr. MUNISH THAKUR
*JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA)
^*neetu.kaushal11@gmail.com

ABSTRACT
Abbreviated New Drug Application (ANDA) is an application used for regulatory submission for the authorization of generics drugs and its entry into a brand drug market. Generic drugs are pharmaceutical equivalent to the brand name drugs and distributed without patent protection. Different countries have different requirements for the registration of generic drugs and its own regulatory authority, which are responsible to enforce the rules and regulations, issue the guidelines to regulate the marketing of drugs. Various government agencies in regulating drugs are CDSCO- India, EDQM-Europe, and USFDA-US. Aim of title was to review the generic drug filing and different aspect of obtaining regulatory approval in order to get the marketing authorization in India, Europe & US. Involvement of regulatory in the generic drug development expedites the approval process and they review the queries carefully raised by the regulatory authorities and minimize them. To harmonize the different requirements, CTD format is used for filing the ANDA in respective countries. In this an attempt was made to highlight the difference between the registration requirements for generics drugs in India, Europe & US. The comparison parameters in the generic drug approval among different regions, which gives clear illustration where India lies in its generic drug approval process.

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Narinder Singh*, Surya Prakash Gautam, NeelamKumari,Rupinder Kaur,Manpreetkaur
CT Institute of Pharmaceutical Sciences, Shahpur, Jalandhar, Punjab
^*pharmacist.narinder@gmail.com

ABSTRACT
Virosomes are reconstituted viral envelopes that can fill in as vaccines and as vehicles for cell conveyance of different macromolecules. The prospect of drug delivery and targeting systems utilizing virosomes is an intriguing innovative work field. Since virosomes are biocompatible, biodegradable, non-poisonous and non-autoimmunogenuic; endeavors have been made to use them as antibodies or adjuvants and also conveyance frameworks for drugs and organic for remedial purposes. The achievement of virosomal medicate conveyance relies on upon strategy used to set up the typified bioactive materials and fuse them into the virosomes. Virosome innovation could conceivably be utilized to convey peptides, nucleic acids or, then again qualities and medications like anti-toxins, anticancer agents, and steroids.

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BALVINDER SINGH¹*, PAWAN JALWAL ¹, VIKASH KUMAR RUHIL ², NEHA MINOCHA¹
1.Department of Pharmaceutical Sciences & Research, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, India
2. P.D.M. College of Pharmacy, Bahadurgarh, Haryana, India
balvindersinghpharmaco@gmail.com

ABSTRACT
B.Pharmacy course is one of the leading professional courses in India. Two types of examinations are prevalent in B.Pharmacy course. One is the sessional examinations for internal evaluation. Second is the semester end/year end examination. Each examination has its own importance. The student should be well prepared for appearing in the examination. Appearing in the B.Pharm. Examination is not only merely science but it requires amalgamation of science and art.

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.

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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.

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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.