REVIEW OF LITERATURE - FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF STAVUDINE
Review of literature
Literature review shows
that no work has been published on the sustained release matrix tablets of
Diltiazem HCL. Some of the published reports of similar work for various
medicinal agents are:
Reddy et al. [7] have prepared the sustained-release matrix tablets of
nicorrandil by the wet granulation
method by using granulating agents Viz ethylcellulose,eudragit RL-100, eudragit
RS-100, and polyvinylpyrrolidone along with
hydroxypropyl methylcellulose, Sodium carboxy methylcellulose.
Wu
et al. [8]
have optimized the
formulation and evaluation of the extended- release tablets of propranolol by
using HPMC and MCC as a polymers.
Mura
et al. [9]
have prepared the
enfluence of formulation and process variables on invitro release of
theophylline of matrix tablets by direct compression of drug and different PH-
dependent (Eudragit L100, S 100, L 100-50) and PH- independent (Eudragit RLPO
and RSPO) polymer combination.
Hayashi
et al. [10]
have compared the formulation study and drug release mechanism of a new theophylline sustained
release preparation by two matrix
tablets with different release mechanisms.
Hayashi et al. [11] have studied the invitro and invivo
sustained-release characteristics of theophylline matrix tablets and novel
cluster tablets.
Mura
et al. [12]
have prepared the sustained-release matrix tablets of metformin hydrochloride in combination with
triacetyl-b-cyclodextrin, by direct compression method.
Tadros et al. [13] have studied the design and in-vitro/
in-vivo evaluation of novel nicorrandil extended release matrix tablets based
on hydrophilic interpolymer complexes and a hydrophobic waxy polymer.
Kojima
et al. [14]
have prepared the extended release of a large amount of highly water- soluble
Diltiazem hydrochloride by utilizing counter polymer in polyethylene oxides and
polyethylene glycol matrix tablets.
Reppas
et al. [15]
have compared the different release apparatus in generating in vitro- in vivo
correlations for extended release matrix tablets.
Garbacz
et al. [16]
have compared the dissolution profiles obtained from nifedipine extended
release formulation using different dissolution test apparatuses.
Hoag
et al. [17] have
studied the sustained release dosage forms and dissolution behaivour
prediction of matrix tablets using NIR spectroscopy.
Khan
et al. [18]
have studied the formulation and evaluation of sustained release matrix tablets
of propranolol hydrochloride using sodium carboxymethyl guar as rate sustaining
polymer.
Keny
et al. [19]
have pepared the formulation and evaluation of minocycline hydrochloride
extended release matrix tablets, by wet granulation technique.
Morkhade
et al. [20]
have prepared the gum copal and gum damar: novel matrix forming materials for
sustained drug delivery, by wet granulation technique using isopropyl alcohol
as a granulating agent.
Tajiri
et al. [21]
have studied the dosage form design and in vitro/ in vivo evaluation of
cevimeline extended-release tablets, by two types simple matrix tablets and
press-coated tablets (hydroxyl-propylcellulose).
Mouao
et al. [22]
have studied the dissolution parameters for sodium diclofenac-containing
hypromellose matrix tablets, by the wet granulation technique (HPMC, magnesium
stearate, PVP, MCC, and lactose).
Modhal
et al. [23]
have studied the development and optimization of sustained release matrix
tablet of ambroxol hydrochloride using central composite design, by direct
compression technique using methodcel K15M CR as matrix former.
Hiremath
et al. [24]
have formulated and evaluated sustained-release matrix tablets of metoprolol
tartrate by direct compression technique using HPMC and carbopol-940 as a
polymers.
F Feleke et al 42 prepared the matrix tablets of stavudine using HPMC.
Robert et al 43 prepared the extended release bead-lets of stavudine. S K Sahoo
et al 44 prepared the microcapsules of stavudine using combination of ethyl
cellulose and PVP.
Suresh et al 45 studied PL GA microcapsules of stavudine. Recently US FDA
approved the long acting stavudine capsule of stavudine with brand name of
ZERIT XR46.
Samal et al. developed oral sustained release matrix
tablets of an antiretroviral drug, zidovudine. Matrix tablets were prepared by
wet granulation method using various proportions of hydrophilic polymers like
Sodium CMC, HPMC, Eudragit‐L155,
& Xanthan gum along or in combination with hydrophobic polymer ethyl
cellulose. The release kinetics was
analyzed using zero order, first order, Higuchi and Hixson Crowell model. From
this study it was concluded that presence of sodium CMC gives zero‐order release kinetics and the
linearity ranges from 0.990 to 0.996. It has also good drug entrapment
efficiency ranging from 96 to 106% of drug. Formulation containing sodium CMC
with Xanthan gum and EC gives sustained release for drug more than 12hrs.10
Atul Kuksal et al., prepared extended-release matrix
tablets of anti retroviral drug, zidovudine using hydrophilic polymers Eudragit
RLPO and RSPO alone or in combination with hydrophobic polymer Ethyl cellulose.
The in-vitro drug release study revealed that either Eduragit preparation was
able to sustain the drug release only for 6 hours (94.3% ± 4.5%release).
Combining Eudragit with ethyl cellulose sustained the drug release for 12 hours
(88.1% ± 4.1% release). 11
Patel Sunilkumar et al., formulated sustained release matrix of
NSAID ibuprofen by using matrix polymer HPMC and ethyl cellulose alone and in
combination. Drug release study was carried out using BP apparatus 2 in pH 7 buffer for 12 hr at 1 hr sampling interval. The results of dissolution study concluded
that the release of drug from matrix prepared from different ratios of both
HPMC and EC gets more retarded than from HPMC and EC alone.12
Subramaniam
Kannan et al.,
developed sustained release tablets of NSAID, aceclofenac (200mg) by wet granulation using hydrophilic
polymer like Hydroxy propyl methyl cellulose K -100. They showed the drug
release from optimized formulations was extended for a period of 24 hrs. The
kinetic treatment of selected formulations showed that the release of drug follows
zero order models. This study indicated the suitability of hydrophilic polymers
in the preparation of matrix based sustained release formulations of NSAID.13
SC Basak et al., prepared Monolithic matrix tablets of
ambroxol hydrochloride, formulated as sustained release tablets employing
Hydroxy propyl methyl cellulose polymer by direct compression process. The results of dissolution studies indicated
that formulation containing drug to polymer in the ratio of 1:1.47, as the
successful formulation exhibiting drug release pattern very close to
theoretical release profile. A decrease in release kinetics of the drug was
observed on increasing polymer ratio. The mechanism of drug release from
optimized formulation was diffusion coupled with erosion (anomalous).14
Deepika V et al., formulated the sustained release matrix tablets of an
anti retroviral drug, zidovudine. In this the sustained release matrix tablets
were prepared by wet granulation method by using hydrophilic polymers like
HPMC, SCMC and Na Alginate. The optimized formulation was further modified
using different hydrophobic polymers as granulating agents, such as PVP,
Eudragit RL100 and Ethyl cellulose to control the drug release. They found that
the hydrophilic matrix of HPMC alone could not control the antiretroviral drug
release effectively for 12 hours. Kinetic treatment to the in vitro release
data revealed that the drug release followed first order release and mechanism
of drug release is by Non-fickian transport.15
Mohd Abdul Hadi et al., prepared zidovudine controlled release
beads by ionotropic gelation method, using sodium alginate containing KHCO3
as the gas-forming agent. The kinetic studies revealed that the drug was
released by zero-order kinetics. It was concluded that the floating beads
designed for the gastro retentive dosage form could be suitable for controlled
drug delivery.16
Kar RK et al., formulated and evaluated
oral controlled release matrix tablets of zidovudine by direct compression
method using various proportion of hydrophilic polymer along or in combination
with hydrophobic polymer. Dissolution study revealed that either Eudragit RS100
or RL100 10%, 20% w/w of tablet preparations were able to sustain the drug
release up to 9 hours, but 30%, 40% as well as EC combination with 20% and 25% w/w of Eudragit RS100 and RL100 were
able to sustaining the drug release for 12 hour.17
Punna RR et al., designed lamivudine (LMV)
oral controlled release matrix tablets using Hydroxypropyl methylcellulose as a
retardant polymer and showed good extension release of LMV and overcome the
disadvantages of conventional tablets of LMV.18
Evelyn O et al., investigated the effect of
ethyl cellulose and 6 types of HPMC (Methocel K100M, K100MPRCR, K15MPRCR,
K4MCR) on release profile of theophylline from matrix tablets was evaluated.
Tablets were prepared either by wet granulation method or direct compression
technique. Drug dissolution tests showed that formulations with 15% of
Methocel K4MPR, 15% of Methocel K4MPRCR
and 30% of Ethocel N10STD, obtained by direct compression method, compiled with
official specifications, in terms of release profile and diffusion was the main
mechanism involved in theophylline delivery.19
Vueba ML et al., studied of different
ketoprofen: excipients formulations, in order to determine the effect of the
polymer substitution and type of diluents on the drug-release mechanism. The
analysis of the release profiles in the light of distinct kinetic models led to
the conclusion that the type of polymer did not influence the release mechanism
of the drug. Moreover, the drug-release process was found to be slightly
influenced by the type of diluents.20
Harris SM et al. , developed a once-daily
sustained release matrix tablet of ibuprofen using HPMC by directly
compression. Different dissolution models were applied to drug release data in
order to evaluate release mechanisms and kinetics. The drug release data fit
well to the Higuchi expression. Drug release mechanism was found as a complex
mixture of diffusion, swelling and erosion.2
Comments
Post a Comment