| 1 |
Author(s):
Ms. Prdnya S. Naykodi, Ms. Priyanka R. Dabhade.
Page No : 1-3
|
A REVIEW ON BIOCATALYSTS IN ORGANIC SYNTHESIS
Abstract
Biocatalysts are enzymes, whole cells,
organelles, and viruses that catalyze chemical
reactions in organic synthesis. They offer many
advantages over traditional chemical catalysts,
including higher reaction rates and improved
product yields. Biocatalysis can be used to
generate complex molecules from simpler
substrates and provide insight into future
applications in green chemistry. Biocatalysts
can be used to catalyze a variety of organic
reactions, including hydrolysis, esterification,
and amination. They offer several advantages
over traditional chemical catalysts in that they
are more specific for their substrates and less
likely to cause side reactions. In addition, they
are often renewable and/or recyclable and
generate less waste.
| 2 |
Author(s):
Dr. Vandana P. Patil, Ms. Suwarna H. kale.
Page No : 4-6
|
REVIEW OF ABBREVIATED NEW DRUG APPLICATION (ANDA) DRUG DEVELOPMENT PROCESS
Abstract
The Abbreviated New Drug Application
(ANDA) drug development process is an
important part of the pharmaceutical industry.
It's a streamlined process for getting generic
drugs approved in the United States. It doesn't
require clinical trials or extensive safety studies,
making it faster and cheaper than traditional
drug approval processes. ANDAs are submitted
to the FDA in order to market a generic version
of a drug that has already been approved. The
ANDA process can take anywhere from 6
months to 2 years. Generic drugs must be
bioequivalent to the innovator drug, and they
may not be able to make significant changes to
the formulation or manufacturing process.
There is always the possibility that patent
litigation could delay or prevent generic entry
into the market.
| 3 |
Author(s):
Mrs. Manisha V. Vitore, Ms. Pradnya S. Naykodi.
Page No : 7-9
|
REVIEW ON LIPID NANOPARTICLE CHARACTERIZATION
Abstract
Lipid nanoparticles (LNPs) have been
developed as a novel method for drug delivery.
They are composed of a hydrophobic core
surrounded by a lipid bilayer. LNPs offer many
advantages over traditional delivery systems
such as better stability and biodistribution.
However, their chemical composition and
physical properties can vary greatly depending
on their method of production and formulation
conditions. Lipid nanoparticles are an attractive
delivery platform for therapeutics and vaccines
due to their ability to protect drugs from
degradation, target specific cell types, and
minimize side effects. Characterization of
LNPs is essential for understanding how they
interact with cells and tissues, as well as for
optimizing their formulation and
manufacturing. With improved methods for
LNP characterization, it may be possible to
unlock the full potential of these particles for
therapeutic and vaccine delivery.
| 4 |
Author(s):
Dr. S. S. Angadi, Dr. G. A. Vaishnav.
Page No : 10-13
|
REVIEW ON INHALATION FORMULATION DEVELOPMENT
Abstract
Inhalation drug delivery via inhalation is a
well-established and widely used method for
delivering drugs to the lungs. Inhalation
developers work to ensure that the drug is
effective when inhaled and that it does not
cause any adverse effects. The goal of
inhalation formulation development is to
produce a formulation that will be safe and
effective for the intended patient population.
Inhalation formulation development is a
complex process that involves many different
factors. Particle size is one of the most
important considerations in this process, as it
can impact both the efficacy and safety of the
final product. There are a variety of methods
available for particle size analysis, each with its
own advantages and disadvantages. The GSD
is a unitless quantity that provides a measure of
how widely dispersed the particles are in terms
of their sizes. It can be used to compare
different particle size distributions or to track
changes in the dispersion of a particle size
distribution over time. The GSD can be
affected by many factors, including changes in
temperature, humidity, and pressure.
| 5 |
Author(s):
Dr. Sushama G. Vaishnav, Dr. G. A. Vaishnav.
Page No : 14-17
|
REVIEW OF REGULATORY CONSIDERATIONS FOR TOPICAL FORMULATION DEVELOPMENT
Abstract
Topical formulation development is governed
by a number of regulatory agencies, including
the US Food and Drug Administration (FDA),
European Medicines Agency (EMA) and
Japanese Pharmaceuticals and Medical Devices
Agency (PMDA). The three main types of
topical formulations are ointments, creams, and
gels. The FDA recommends that only active
pharmaceutical ingredients (APIs) be included
in topical formulations. These include
transdermal patches, liposomal preparations,
and microparticulate systems. Topical
formulations are easy to use and generally welltolerated by patients. The FDA has strict
guidelines for the development and testing of
topical products. Failure to comply with these
regulations can result in delays or rejection of
your product. In this section, we share some
recipes for common topical formulations, such
as lotions, creams, gels, and ointments.
