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The idea for writing this basic HPLC book was probably born during
the project sanctioned by University Grants Commission - Pune. This
book was written as an updated reference guide for busy laboratory
analysts and researchers. Topics covered include HPLC operation,
method development and validation aspects. This book can serve as a
supplementary text for students pursuing a career in analytical
chemistry. It describes basic theories and terminologies for the
novice and reviews relevant concepts, best practices, and modern
trends for the experienced practitioner. A reader with a science
degree and a basic understanding of chemistry is assumed.
I had studied development aspects of sustained release microspheres
of Diclofenac sodium that release the drug Up to 24 hour and
improve Bioavailability of Diclofenac Sodium by using spray drying
and simple solvent evaporation technique.Preparation of Chitosan
Microsphere with Diclofenac Sodium by various techniques such as
spray drying and simple solvent evaporation technique. For Spry
Drying technique the optimization of Spry Dried Parameter such as
inlet Temperature and Feed pump Rate. Optimization of Temperature
by taking the 130 degree C, as a starting Temperature and showing
the Characteristic of Microspheres. Study Shows that the fine
Partical were found in 150 degree C. Temperature, Feed Pump rate
was also optimizes by this way and 2ml/min feed pump rate shows
good Microspheres with higher %yield. So parameters were taken 150
degree C temperature and 2ml/min feed pump rate and Microspheres
were Prepared. Further study with Drug to polymer ratio like
1:1,1:3 and 1:5 are carried out.As increase in the drug to polymer
ratio from 1:1,1:3 and 1:5 the Entrapment efficiency was also
increase and the release rate were Extended.
Oral drug delivery is the most widely utilized route of
administration among the entire route that has been explored for
the systemic delivery of drug via various pharmaceutical products
of different dosage form. The conventional tablet seems to be most
popular because of its ease of transportation and low manufacturing
cost as compare to others but poor patient compliance with whom
experienced swallowing difficulties. In response to this mouth
dissolving drug delivery system (MDDs) were developed as an
alternative to tablet, capsule and syrup. A variety of MDDs like
Mouth dissolving tablets (MDTs) and Mouth dissolving films (MDFs)
were commercialized. This book describes the design and development
of sildenafil citrate mouth dissolving film. As sildenafil citrate
is a widely utilized drug for erectile dysfunction. This produced
mouth dissolving film prepared by newer polymer Kollicoat protect
and showed the good alternative for the other mouth dissolving film
former, specially HPMC. Stevioside a natural sweetener used and
showed the potency to mask the bitter taste of sildenafil citrate.
Hence, MDF of sildenafil citrate provide good alternate to other
available dosage form.
Manufacturing area with new equipment having high capacity compared
to previous one (Production Line) i.e. FBD, RMG, Co Mill and
Container Mixer. Manufacturing of Metformin ER 500mg tablets is
planned to do in new area with new equipment. As the size and
capacity of the equipments are bigger than previous equipments,
batch size of Metformin ER tablets is increasing from 0.4 mio to
0.6 mio. As the production in new area and new equipment,
qualification of area, equipment, water and air was carried out as
per qualification protocol. Now, further the process of
optimization was performed for Metformin ER tablets by identifying
the critical Process parameters i.e. standardization batch (BATCH
I). Before going to start process validation, one standardization
batch was taken, where the process optimization of critical
parameter like mixing speed, mixing time, lubrication time was
carried out; fast, 15 min, 15 min respectively the results for
that. Three process validation batches (PV-1, PV-2 and PV-3) of
commercial batch size were taken in which Manufacturing Process,
critical parameters, Validation status of equipments &
Validation criteria's were considered.
Carvedilol has unique pharmacological profile. It blocks 1, 2, and
1 receptors, used in the management of hypertension and as an
adjunct to standard therapy in symptomatic heart failure and also
produces vasodilation. In the present study, an attempt has been
made to improve drug concentration in the stomach by preparing
gastroretentive floating microsphere of carvedilol phosphate to
maintain drug levels within a desired range, reduce dosing
frequency, Improve patient compliance, improve dissolution and at
the site of absorption.Drug molecules presenting no difficulties in
their solubility and/or absorption problems are good candidates for
oral controlled release formulations but Obstacle may arise for
many drugs related to their solubility and/or absorption that may
be overcome by formulating Gastroretentive systems which prolong
the gastric retention time, improves solubility and hence improves
bioavailability for drugs that are less soluble in a high pH
environment.
To formulate and evaluate time dependent pulsatile drug delivery
system of Montelukast sodium to deliver the drug with biological
rhythm of asthma after predetermined lag time 5:30 hours. In
preliminary study, The core tablet of Montelukast sodium was
prepared by using direct compression method containing SSG,
Croscarmellose sodium, Crospovidone, MCC and Starcap1500 to obtain
fast disintegrating tablet for the selection of super
disintegrating agent. PVAP, CAP and Ratio of Eudragit L 100:
Eudragit S 100 was used as pH dependent polymer for coating the
core tablets. Total 9 batches were formulated as per 32 full
factorial design applied to check the effect of polymer ratio
(Eudragit L 100: Eudragit S 100) and the effect of % weight gain on
dependent variable lag time PRTs. These formulations were evaluated
for physical parameters of tablet, drug -excipient compatibility
study, lag time of rupture of PRTs and in-vitro drug release study.
PDDS of Montelukast Sodium formulated using Croscarmellose sodium
as super disintegrant and Eudragit L 100 and Eudragit S 100 as a
coating polymers. Formulation M7 can provide site specific delivery
with sigmoidal drug release.
In present research work, dispersible tablets of cefpodoxime
proxetil were formulated using dry granulation technique.
Cefpodoxime proxetil is an advanced-generation, broad-spectrum
cephalosporin antibiotic. Cefpodoxime proxetil has slightly bitter
taste and has poor water solubility. So in case of acute bacterial
exacerbation of chronic bronchitis (AECB) groupA beta-hemolytic
streptococcal pharyngotonsillitis, and uncomplicated skin/skin
structure infections it require immediate release of drug from the
dosage form, which make Cefpodoxime Proxetil suitable candidate for
dispersible tablets.
The purpose of this study was to develop and evaluate a drug
delivery system in vitro based on a compression coated tablet
containing 5-fluorouracil (5-FU) in core and pectin Hydroxypropyl
Methylcellulose (HPMC) mixture in coat layer. The main reason for
selecting pectin was its biodegradation in colon by colonic flora.
On other hand, high molecular weight HPMC increases mechanical
strength of tablet coat around a drug core during its
transportation in gastro-intestinal tract. Multiple regression
analysis with two way ANOVA revealed that both factors had
statistically significant influence for the response studied (P
The purpose of this research was to formulate tasteless complexes
of Fexofenadine Hydrochloride with Kyron-134 and to formulate
tasteless complex into fast-Dispersible tablets (FDT) for the
treatment of allergic rhinitis & chronic idiopathic urticaria.
Drug release from FDT in salivary pH was insufficient to impart
bitter taste. Complete drug release was observed at gastric pH. The
studies indicate that the formulation was taste masked drug can be
formulated in to FDT with view to enhance patient compliance &
to obtain faster onset action of the drug which would be
advantageous in comparison to the currently available conventional
forms. Formulations D-5 was found to be palatable with in vitro
disintegration time of 20 s Dissolution studies showed complete
release of D-5 within 30 min.
Itopride, a novel prokinetic agent is unique and different from the
available prokinetics because of its dual mode of action and lack
of significant drug interaction potential. Itopride is a newly
developed prokinetic agent, which enhances gastric motility through
both anti-dopaminergic and anti-acetylcholinesterage actions. It is
best candidate for Gastro Esophageal Reflux Disease. Itopride 50mg
can be given thrice in a day for Treatment of GERD. By developing
the sustain release formulation of Itopride hydrochloride, the
frequency of drug can be reduce to once only to obtain good
therapeutic response. The prepared formulation is usually taken on
an empty stomach about an hour before meals. Sustained release
tablet of Itopride Hydrochloride was prepared by using combination
of HPMC grade as matrix forming material. The influence of amount
of Hydroxypropyl Methylcellulose K15M and Hydroxypropyl
Methylcellulose K100M on release of Itopride hydrochloride was
studied using Central composite design. The optimized Formulation
FB7 had given prolonged drug release up to 24 hr. It also had
desired drug release kinetics and it was found to be stable after 1
month at accelerated conditions.
Nicotinic acid (NA) as lipid lowering agent drug has not become a
first-line treatment due to the strong side effect called flushing
occurs when given in immediate release dosage form. The tablets
were prepared by wet granulation method using HPMC K-15M, polymer
as retardant and the prepared tablets of NA will remain intact up
to 2 hrs in pH 1.2 due to Eudragit L 100-55 and its release is not
only initiated but tact fully retarded up to 12 hrs and were found
to be superior in physical properties, dissolution characteristics,
and drug content uniformity. The drug release from the matrix
tablet Fitted to the Higuchi model and Zero order release which
indicates non-Fickian diffusion.N8 showed good similarity with
theoretical profile of nicotinic acid. Excipients has significant
effect on drug release, because DCP retarded the release due to
hydrophobic nature, on the contrary MCC increased drug release for
its swelling property and causing burst release, and lactose
moderately affected drug release due to channeling action and hence
causing drug release at desired rate and amount. The studies
indicate that the formulation was effective in providing in vitro
release for extended perio
Tolperisone hydrochloride has a short elimination half- life and
rapidly absorbed from gastrointestinal tract.2 If it is formulated
by conventional tablets, it will require multiple daily
administrations (2-3 times daily) which ultimately results into in
conveniency to the patients and possibility of reduced compliance
with prescribed therapy. Tolperisone HCl is more stable in acidic
medium (pH > 4.5), and in alkaline medium (pH 4 to 7)
tolperisone breaks down into 4-MMPPO and piperidine. Thus, the
patient is exposed to an uncontrollable quantity of 4-MMPPO
2methyl-1-(4methylphenyl)-propanone]. Proposed are floating
tolperisone tablets with the controlled release of the active
substance tolperisone in the stomach at pH 1 to 2.
The objective of this study is to develop controlled porosity
osmotic pump tablet of Verapamil Hydrochloride, which is an
antihypertensive candidate, using Polyethylene glycol (PEG) 400 as
pore former in Cellulose acetate semipermeable membrane and
Mannitol as a osmotic agent which release drug for extended period
of time (24 h) and drug release of optimized formulation is
independent of pH and agitation speed with zero order release.
In the present investigation, solid dispersion of olanzapine has
been prepared to improve its solubility. Further, using solid
dispersion, mouth dissolving tablet was prepared to overcome the
problem of swallowing. A Simplex Lattice design was applied using
three factors, i.e. superdisintegrants like croscarmellose
sodium(X1) crospovidone(X2), and sodium starch glycolate(X3) in
tablet formulation. Disintegration time, Wetting time, Water
absorption, T50 (Time required to 50% drug release) and Q10
(percentage of drug released in 10 min.) taken as responses. Solid
dispersion showed significant enhancement in solubility of
olanzapine. For mouth dissolving tablet, batch containing 5%
croscarmellose sodium alone had minimum disintegration time (44
sec.) and faster drug release(T50: 40 sec) compared to other
batches.
Colorectal cancer is second leading cause of deaths in the United
States. Various approaches available for The poor site specificity
of pH dependent systems, because of large variation in the pH of
gastrointestinal tract, was well established. The timed-release
systems release their load after a predetermined period of
administration. These are designed to resist the release of the
drug in stomach and small intestine and release of the drug takes
place in colon. Methotrexate (MTX) is a used in the treatment of
colon cancer and now a days rheumatic disease. MTX is a folate
antimetabolite. MTX has since been used in the treatment of various
malignancies including osteosarcoma, non-Hodgkin's lymphoma,
Hodgkin's disease, cutaneous T cell lymphoma, lung cancer, colon
cancer and breast cancer. The conventional dosage forms which are
used for colorectal cancer normally dissolve and absorbs in the
stomach and small intestine; thus a very less quantity of dose of
drug reaches to colonic region. Aim of present work is to develop
and characterize colon targeted tablet of MTX for for treatment of
colorectal cancer using different polymer and excipient by
compression coating technology.
To develop sustained release matrix tablet of Tramadol HCl that
deliver drug for 24 hr and to be taken once in a day. Drug having
high solubility and relatively shorter half-life suggests its
suitability for an extended formulation. If it is formulated by
conventional tablets, it will require multiple daily
administrations which ultimately results into inconveniency to the
patients and possibility of reduced compliance with prescribed
therapy. Also fluctuation in plasma drug concentration leads to
exaggerated side effects, this all limitations can be minimized by
adopting extended release formulation. To reduce the frequency of
administration and to improve the patient compliance, Once in a day
sustained release formulation is desirable. It describes the
influence of the concentration of HPMC K4M, HPMC K15M and HPMC
K100M on Tramadol HCl sustained release formulations using
box-behnken design.These Polymers were selected as an independent
variables. Drug release after 8 hr, 12 hr and 16 hr were selected
as a dependent variables. Optimized formulation found by similarity
and dissimilarity factor follow zero order kinetic with non-fickian
diffusion as a drug release mechanism.
Famotidine is histamine -H2 receptor antagonist. It has
bioavailability of 40 to 45% and it has shorter plasma half life of
2.5 to 3.5 hrs. The effective treatment of erosive esophagitis and
Zolinger-Elisons syndrome requires administration of 20 mg of
Famotidine 4 times a day. A conventional dose of 20 mg can inhibit
gastric acid secretion up to 5 hours but not up to 10 hours. An
alternative dose of 40 mg leads to plasma fluctuations; thus a
sustained release dosage form of famotidine is desirable. Direct
access to the systemic circulation bypasses drugs from the hepatic
first pass metabolism leading to high bioavailability. Moreover,
the buccal route is easily accessible, has a good patient
compliance and can be used in patients who can't swallow. Bilayer
buccal tablet was prepared by using mucoadhesive polymer
combination of Sodium CMC and Carbopol934P, by direct compression
with backing layer of Ethyl cellulose. The optimized formulation F1
had given release of 102.57% in 8hrs and it had optimum swelling,
mucoadhesive property and permeation from buccal mucosa. It also
had desired drug release kinetics and found to be stable for the
period of 1 month.
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