Showing posts with label Pharma News. Show all posts
Showing posts with label Pharma News. Show all posts

Thursday, July 1, 2021

INTERNATIONAL JOURNAL OF MEDICAL, PHARMACEUTICAL AND BIOLOGICAL SCIENCES (IJMPBS) LAUNCHED ITS FIRST ISSUE


INTERNATIONAL JOURNAL OF MEDICAL, PHARMACEUTICAL AND BIOLOGICAL SCIENCES (IJMPBS)

International Journal of Medical, Pharmaceutical and Biological Sciences (IJMPBS) has launched today its first issue, April-June 2021. This issue comprises of total seven article which includes one editorial article written by the editor in chief. Anjali Pawar. The abstract of the other articles is summarized below:

1. Title: NANOFIBER AND CANCER - AN OVERVIEW OF RECENT DEVELOPMENTS

Authors: Iyer Aditya Manivannan, Syed Tazib Rahaman

Abstract: Cancer is a disease of grave concern. To combat the alarming need to provide an effective treatment methodology, Nanotechnology has become a powerful tool. It aids in achieving target-specific drug delivery to the tumour site. Nanofibers are among such nano-bio materials that can encapsulate antitumor drugs. In this review we tried to enlist various commercial nano-formulations, comprehend electrospinning as a means of developing nanofibers, brief on natural, semisynthetic and synthetic polymers such as Zein, Chitin, Chitosan, Poly-lactic acid, Poly lactic-co-glycolic acid, and Polycaprolactone suitable for nanofiber preparation, and applications of Nanofibers in delivery of a single drug as well as a combination of drugs or theranostic agents in cancer. It also describes three mechanisms of drug release from nanofibers, namely, pH-responsive, thermoresponsive and magnetic-heat composite release. The review tabulates the recent developments enlightening the applications of nanofibers in cancer chemotherapy in the past two decades. Nanofibrous mats are effective systems for localized treatment involving monotherapy, combination therapy, as well as for concomitant delivery of drugs and imaging agent, or genes. They have potential applications in the prevention of post-surgical cancer recurrence. Nanocomposite systems confer the ability to modulate drug release. Systems like nanoparticles which suffer from poor circulation time can be incorporated within nanofibrous mats. With many such unforeseen advantages and merits, Nanofiber becomes a potential nanotechnology driven system that enables patient-centric therapy for grave conditions like cancer. Read more

2. Title: MORPHOLOGICAL, PHYTOCHEMICAL AND PHARMACOLOGICAL ASPECTS OF SYZIGIUM CUMINI

Authors: Anjani M. Nikhare, Wrushali A. Panchale, Amar F. Sabhadinde, Jagdish V. Manwar, Ravindra L. Bakal

Abstract: Syzygium cumini, family Myrtaceae, a medicinal plant with numerous pharmacological activities such as anti-diabetic, antioxidant, anti-hyperlipidic and hepatoprotective. Seeds are moderately rich in protein and various phytochemicals along with flavonoids quercetin and, rutin a well-known antioxidant. Its leaves are used to treat leucorrhoea, stomachache, fever, dermopathy, constipation, inhibit blood discharge in feaces and reduce radiation induced DNA damage. Jamun fruit is an effective food remedy for bleeding piles and correcting liver disorders. This will help in confirmation of traditional use along with value-added utility of plant eventually leading to higher revenues from the plant. Read more

3. Title: DEVELOPMENT AND EVALUATION OF TASTE MASKED FORMULATIONS OF FEXOFENADINE HYDROCHLORIDE

Authors: Eshani Pradeep Rane,  Meghana Babar

Abstract: Ease of administration and patient compliance is gaining significant importance in the design of dosage forms. Dysphagia (difficulty in swallowing) is a common difficulty among all age groups especially in elderly and pediatrics. Patients suffering from dysphagia show greater chances of being choked during consumption of liquid formulation. Thus, to mollify such a problem, liquid formulation of high viscosity was prepared. The objective of present research work was to design and develop pediatric taste masked formulations of Fexofenadine hydrochloride (FEH) with taste enhancement and improved bioavailability. The masking of bitter taste of the drug was a necessity to formulate it in a palatable form. Effective taste masking of Fexofenadine hydrochloride was achieved through complexation with selected cyclodextrin (2- Hydroxypropyl beta cyclodextrin/ Cavasolw7HP). Inclusion complex prepared by solid dispersion showing taste score 1 (tasteless) was selected and further subjected to in-vitro taste assessment study. Based on human panel studies, tasteless FEH-2HPBCD complex i.e., batch FE5 was selected as optimized batch and different child friendly taste masking technologies were screened for incorporation of the same. Oral flavored powder formulations were prepared by mixing drug-2HPBCD inclusion complex equivalent to 30mg of FEH with varying concentrations of sucralose and with different flavors like chocolate, lemon, cherry, pineapple, etc. Formulation batch contaning lemon flavor F4 was more acceptable to human volunteers. Effervescent granules were formulated by using different concentration of effervescent salts, sucralose and lemon flavor. Soft chewable lozenges were formulated by optimization for binder concentrations and various flavors like chocolate, cherry, lemon, pineapple, etc. Results conclusively demonstrated that successful taste masking of FEH was accomplished and that it could be formulated for oral administration with more acceptability to pediatrics and improved bioavailability. Read more

4. Title: ORALLY DISINTEGRATING FILM: AN INNOVATIVE AND EASY APPROACH

Authors: Mohd Saif Mohd Akram Momin, Neha Inayat Hussain Ansari

Abstract: Orally disintegrating film (ODF) is a novel and simple method for delivering therapeutically or medicinally active chemical substances to the body(s). The major goals of orally disintegrating films (ODFs) are to improve drug’s bioavailability, permeability, and time to action, as well as enhance patient compliance. The process of making films is identical to that of making a transdermal patch. When a film is placed in the mouth, salivary fluid causes it to disintegrate quickly, releasing the medication(s). The medication(s) will subsequently be absorbed into the bloodstream, revealing therapeutic effect. This overview covers the pros and demerits of ODF formulations, as well as formulation aspects, technologies involved in making ODF formulations, and evaluation tests conducted for the same, as well as packing and storage. Orally disintegrating film formulations are a unique dosage form designed to enhance drug delivery, therapeutic action, and patient compliance. Read more

5. Title: COVID-19 VACCINES APPROVED FOR EMERGENCY USE AND UNDER DEVELOPMENT AROUND THE GLOBE – AN OVERVIEW

Authors: Harshal Ashok Pawar, Anjali Harshal Pawar, Sandip Ashok Pawar, Prashant Ashok Pawar

Abstract: COVID-19 has caused extensive human casualties with significant economic impacts around the globe, and has imposed new challenges on health systems worldwide. When the genetic sequence of SARS-CoV-2 was revealed, global vaccine companies and scientists have stepped forward to develop a vaccine, triggering a race toward vaccine development that the whole world is relying on.  Several vaccines against SARS-CoV-2, the virus that causes COVID-19, have been developed. The first vaccines available in the US (by Pfizer-BioNTech and Moderna) are messenger RNA (mRNA) vaccines. Another mRNA vaccine is available in Europe (CureVac). Other vaccines (by Janssen-Johnson & Johnson, Astra-Zeneca, Sputnik-V, and CanSino) are made using human and primate adenovirus vectors. A third type of vaccine available outside of the US is an inactivated whole-virus SARS-CoV-2 vaccine (by Bharat Biotech, Sinopharm and Sinovac). An effective and safe vaccine could play a pivotal role in eradicating COVID-19. However, few important questions regarding SARS-CoV-2 vaccine development are explored in this review. The present review gives an insight into the current status of vaccine development and associated outcomes reported at different phases of trial. Read more

6. Title: OVERTURE IN DEVELOPMENT, PROPERTIES AND CLINICAL ASPECTS OF BIOSURFACTANTS: AN REVIEW

Authors: Ashwini H. Bijewar, Wrushali A. Panchale, Jagdish V. Manwar, Ravindra L. Bakal

Abstract: Biosurfactants are a basically assorted gathering of surface-dynamic substances created by microorganisms. They are amphiphiles, they comprise of two sections- a polar (hydrophilic) moiety and non-polar (hydrophobic) congregation. In spite of a colossal measure of examination work over the most recent twenty years on conserving the creation of biosurfactants, their business accomplishment when contrasted with their manufactured partners actually stays a financial test. Utilization of immobilized organic entity, utilization of NPs, strong state aging, coordinated aging, froth fractionation, and fill and draw method of activity could end up being other promising cycles for the upgraded modern creation of different biosurfactants. Utilization of natural, fortified waste substrates and biosurfactants coproduction with another modern efficient item should be all the more basically concentrated particularly in huge aging vessels. In present work, we have covered various physicochemical and clinical aspects of biosurfactants. Read more

The current issue of the journal is available at : https://www.aphinfo.com/ijmpbs/current-issue




Aarya Publishing House introduced new journal entitled INTERNATIONAL JOURNAL OF MEDICAL, PHARMACEUTICAL AND BIOLOGICAL SCIENCES (IJMPBS)

Aarya Publishing House (APH) is a rapidly growing academic publisher with peer-reviewed, open access journals / books covering a wide range of academic disciplines. APH was established in the year 2013 with its registered office at Kalyan (Maharashtra), India. APH was established with clear cut goal of publishing quality and noteworthy publications. APH has introduced one more new journal entitled INTERNATIONAL JOURNAL OF MEDICAL, PHARMACEUTICAL AND BIOLOGICAL SCIENCES (IJMPBS).

INTERNATIONAL JOURNAL OF MEDICAL, PHARMACEUTICAL AND BIOLOGICAL SCIENCES (IJMPBS)


International Journal of Medical, Pharmaceutical and Biological Sciences (IJMPBS) is a peer reviewed online OPEN ACCESS journal . IJMPBS is intended primarily to promote rapid publication in the fields of Medicines, Pharmaceutical, and Biological Sciences. 

IJMPBS publishes original research work that contributes significantly to further the scientific knowledge in area of Medicine, Surgery, Pharmaceutics, Novel Drug Delivery, Biopharmaceutics, Pharmacokinetics, Nanotechnology, Pharmacognosy, Phytochemistry, Natural Product Research, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacology and Toxicology, Pharmaceutical Analysis, Quality Control, Quality Assurance, Drug Regulatory Affair, Pharmacy Practice, Clinical and Hospital Pharmacy, Pharmacogenomics, Bioinformatics, Pharmaceutical Biotechnology, Microbiology and other related fields. 

The Journal publishes original research work either as a Full Research Paper or as a Short Communication / Case study. Review Articles on a current topic in the said fields are also considered for publication by the Journal.

APH is planning to index IJMPBS with Scopus, Google Scholar, Chemical Abstract Services (CAS), Science Central, Index Copernicus, Pharmaceutical Science Open Access Resources (PSOAR), Rubriq, Directory of Research Journals Indexing, Journal Seeker, Directory of Science, Indian Science.in, Jour Informatics, China Knowledge Research Integrated (CNKI) database and other renowned electronic databases.

The editorial team of IJMPBS is founded by distinguished members of industry and academics from various disciplines and geopolitical region. The journal follows all the international regulatory requirements in order to ensure the quality of the articles and has bright future. The first issue of the journal is released today and it contains seven articles including editorial by the editor in Chief, Anjali Pawar. For more details refer : https://www.aphinfo.com/ijmpbs  (Source of the content).


Monday, June 21, 2021

US FDA Issued Form 483 to Alkem Laboratories Ltd. After Inspection of Its St Louis-based Formulation Plant

An FDA Form 483 is issued to a firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.

US FDA Issued Form 483 to Alkem Laboratories Ltd.


 Alkem Laboratories Ltd., incorporated in the year 1973, is a Large Cap company (having a market cap of Rs 37,343.74 Crore) operating in Pharmaceuticals sector.

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally.

Alkem set up its innovative work office for ANDA improvement at Taloja in 2003. In 2006 enemy of infective medication Taxim of Alkem turned into the principal hostile to infective medication in the Indian drug industry to cross 1,000 million as far as homegrown deals in India. In 2014 Clavam other medication from Alkem crossed 2,000 million imprint as far as homegrown deals in India. In 2007 the organization recorded its first ANDA for drug Amlodipine which was endorsed in 2009. Alkem has fostered an arrangement of 705 marked conventional medications, with 13 of the brands included among the main 300 brands in India for the monetary year 2015 and an arrangement of 705 brands in India in the a half year finished 30 September 2015. Alkem have 21 assembling offices, 19 in India and 2 in US. 5 of the offices are US FDA, TGA, UK MHRA supported.

As on today, Alkem has :

  • 21 Manufacturing units
  • Over 800 brands
  • Business footprint in over 50 countries
  • A 14,500 plus strong workforce
  • Multiple acquisitions and joint ventures
  • Consolidated revenue at Rs. 83,444 million in FY2019-20
Alkem, which has operations spread across multiple territories abroad, produces a complete range of formulations of controlled substances at its finished dosage manufacturing facility in St Louis, Missouri. The US-FDA had conducted an inspection of the company's manufacturing plant at St Louis, USA from June 14-18, 2021.

At the end of the investigation, the company received Form 483 with two observations from the US-FDA. It notifies the company's management of objectionable conditions at the facility.

A FDA Form 483 is given to a firm administration at the end of an inspection when an US FDA auditor has noticed any conditions that in their judgment may establish infringement of the Food Drug and Cosmetic Act and related Acts.

The company shall submit to USFDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.