Volume 9
Issue 2, April 2019
A concise Review on "Good Documentation Practice"
Binny Mehta*, Hemangini Makwana, Pinak Patel, Krunal Detholia
Gastro Retentive Floating Microsphere: A Review
Lalit Kumar*, Abhishek Sharma
Analytical Techniques for Determination of Torsemide and its
Combinations: A Review
Madhuri Hinge*, Dipti Patel
A Review Article on Development of Forced Degradation and
Stability Indicating Studies for Drug Substance and Drug Product
Dharti Patel*, Miral Patel, Keyur Ahir, Sumer Singh
ISSN 2277 - 3681
Indexing & Listing
Impact Factor-2.633
(JIF-2015)
Journal of
Pharmaceutical Science and Bioscientific Research
ABSTRACT:
Documents are a mirror to show actual image of any pharmaceutical company. Such measures that
collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable,
permanent, contemporaneously recorded, original and accurate. Specific topics for discussion include
documentation fundamentals, document creation, document management, best practices in style and layout,
completing documents and record-keeping, electronic records, storage, errors including error correction, and
associated topics
KEY WORDS: Good Documentation Practice, Pharmaceutical Company, Document creation, Document
management.
![[x]](JPSBR_Vol_9_Issue_1_htm_files/close.png "Close")
ABSTRACT:
Drug
delivery
system
should
release
the
drug
according
to
the
body
requirement
during
treatment
and
to
the
target
site.
With
the
passage
of
time
and
development
in
medical
segment
research
was
done
in
field
floating
microspheres
which
reduce
the
dosage
form
drawbacks
like
low
gastric
residence
time
and
unpredictable
gastric
emptying
time.
Floating
microspheres
is
a
technique
of
the
gastro
retentive
drug
delivery
system
having
both
effervescent
and
non-effervescent
mechanism.
Due
to
their
low
density
they
offer
enough
buoyancy
to
float
over
the
gastric
fluids
for
longer
period
of
time
and
thus
increase
the
gastro
retention
time.
Floating
microspheres
also
maintains
desire
drug
concentration
with
minimum
interval
of
frequency
of
drug
dosing
thus
they
can
either
be
formulated
as
sustained
release
or
controlled
release.
The
main
property
of
floating
microspheres
is
that
they
buoyant
over
the
surface
of
gastric
fluid
for
more
than
12
hrs.
This
review
article
comprises
the
detailed
study
of
the
property,
classification,
method
of preparation as well as the characterization of floating microspheres.
KEY WORDS: Gastro retentive drug delivery system, Floating microspheres, Buoyant, Gastric residence time.
ABSTRACT:
Torsemide is chemically 3-pyridine sulfonamide N-[[(1- methylethyl) amino] - carbonyl]-4-[(3-methylphenyl) amino]. Torsemide
is a loop diuretic drug used for treatment of high blood pressure (hypertension). It acts by inhibiting the Na+/ K+/ 2Cl– carrier
system (via interference of the chloride binding site) in the lumen of the thick ascending portion of the loop of Henle, resulting in
the decrease in reabsorption of sodium and chloride. This review focuses on the recent developments in analytical techniques
for estimation of Torsemide alone or in combinations with other drugs in various biological media like human plasma and urine.
This review will critically examine the (a) sample pretreatment method such as solid phase extraction (SPE), (b) separation
methods such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC), ultra performance liquid
chromatography (UPLC), high performance thin layer chromatography (HPTLC), liquid chromatography coupled to tandem
mass spectrometry (LC-MS) and capillary electrophoresis (CE), other methods such as spectrophotometry, diffuse reflectance
near infrared spectroscopy and electrochemical methods.
KEY WORDS: Analytical Techniques, Torsemide, Solid phase extraction, HPLC, Spectrophotometry.
ABSTRACT:
HPLC is an analytical technique widely used for identification, separation, detection and quantification of various drugs and its related degradants. HPLC
Process development is important in case of drug discovery, drug development and in analysis of pharmaceutical products. High performance liquid
chromatography is one of the most accurate methods widely used for the quantitative as well as qualitative analysis of drug product and is used for
determining drug product stability. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the
synthesis or manufacture of drug product. The objective of the review article is to give detailed description and guidance of the forced degradation studies
as per regulatory guidelines. Forced degradation or alternatively referred as stress testing and it demonstrates specificity when developing stability
indicating methods, especially when little is known about potential degradation products. Forced degradation study provides information about the
degradation pathways and degradation products of the drug substance that could form during storage, transportation. Force degradation study also helps in
the elucidation of the structure of the degradation products. Forced degradation study provide the chemical behavior and chemical nature of the molecule
which ultimately helps in the development of formulation during manufacturing and packaging specification, thus this review article provide knowledge of
the current trends in performance of forced degradation study and establishing the analytical methods that helpful for development of stability indicating
method. The stability of drug product and or drug substance is a critical parameter which may affect purity, potency and safety.
KEY WORDS: Degradation, Purity, Potency, Degradants, accelerated conditions, Stress testing.
