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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.
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.
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
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.
Levocetrizine hydrochloride is an oral antihistamine and
antiallergic agent, which blocking histamine receptors. It does not
prevent the actual release of histamine from mast cells, but
prevents it binding to its receptors. This in turn prevents the
release of other allergy chemicals and increased blood supply to
the area, and provides relief from the typical symptoms of hey
fever and rhinitus allergic condition. The dose of Levocetrizine
hydrochloride ranges from 5 to 10 mg twice in a day and it
undergoes extensive first pass metabolism. Hence it has only 66%
bioavailability. The half life of the drug 8 to 10 hours indicates
the need for modified release dosage form. levocetrizine
hydrochloride was chosen as model drug with an aim to developed
fast dissolving tablet that improve bioavailability, patient
compliance and rapid action in rhinitus allergic condition.
The aim of this study was to develop a new intra-gastric oating in
situ gelling system for controlled delivery of levetiracetam for
the treatment of partial onset seizures.High dose of levetiracetam
(750 to 1000 mg) is di cult to incorporate in oating tablets but
can easily be given in liquid dosage form. Sodium alginate-based
in-situ gelling systems were prepared by dissolving various
concentrations of sodium alginate in deionized water, to which drug
and calcium carbonate were added. A 32 full factorial design was
used for optimization. The concentrations of sodium alginate (X1)
and calcium carbonate (X2) were selected as the independent
variables.The amount of the drug released after 1 h (Q1) and 6 h
(Q6) and 12 h (Q12), viscosity and Floating lag time of the liquid
formulation were selected as the dependent variables. The studies
indicate that the formulation was effective in providing in vitro
release for extended time up to 12 hrs and also convenient for
geriatric and paediatric patient and increase drug residency to the
GIT."
Venlafaxine Hydrochloride is an oral antidepressant agent of the
Serotonin-Norepinephrine Reuptake Inhibitor class. Venlafaxine
Hydrochloride has been studied for the treatment of panic disorder,
post-traumatic stress disorder, and the treatment of hot flashes in
patients who cannot or do not want to take hormone replacement
therapy. The dose of Venlafaxine hydrochloride ranges from 75 to
225 mg three times a day and it undergoes extensive first pass
metabolism hence it has only 45% bioavaibility. The short half life
of the drug 5 hr indicates the need for modified release dosage
form. Venlafaxine HCl was chosen as model drug with an aim to
developed mucoadhesive buccal tablet that minimize dose related
side effects and reducing the dosing frequency of drug and finally
improve the bioavaibility.
The aim of present research work is to develop single pulse
pulsatile release tablets that release Lornoxicam instantly after
the lag time of about 5 hour which can be used for treatment of
rheumatoid arthritis where symptoms are at their prime in the
morning hours. Such a pulsatile release tablet of Lornoxicam taken
at bed time and release the drug in early morning, thus enhance
patient compliance. From various approaches erodible compression
coating system is selected for the formulation of pulsatile release
tablets, in which outer coating containing mixture of hydrophilic
polymer (sodium alginate) and hydrophobic polymer (ethylcellulose).
The release profile of compression coated tablet exhibited lag time
followed by burst release, in which outer shell break into two
halves.
Metoprolol Tartrate is a -blocker drug indicated for the treatment
of angina, prevention of myocardial infarction, Essential
hypertension; It has low bioavailability of about 40% due to
hepatic metabolism. The purpose of this research was to improve the
bioavailability by preparing a fast dissolving tablet using
superdisintegrants method. Because pregastric absorption of drug
improves bioavailability, gives rapid onset of action when needed."
The present research work is to design and evaluate an oral time
dependent, pulsatile drug delivery system containing Salbutamol
Sulphate, which can be targeted to time dependent manner, to
modulate the drug level in synchrony with the circadian rhythm of
nocturnal asthma. A time dependent pulsatile dosage form was
developed by using a various grade of HPC in compressed coated
layer. A pulsatile 'Tablet in Tablet' dosage form, taken at bed
time with a programmed start of drug release early in morning
hours, can prevent a sharp increase in the incidence of asthmatic
attacks, during the early morning hours (nocturnal asthma), a time
when the risk of asthmatic attacks is the greatest.
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