BANGALORE, KARNATAKA.
ANNEXURE - II
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6.
BRIEF RESUME OF THE INTENDED WORK:
The poor dissolution of relatively water insoluble drugs as for long had been a problem
in the formulation of oral dosage forms. This limits such as absorption and Bioavailability.
Several approaches have been followed in improving solubility of the drugs, one being
microwave irradiation method to prepare a solvent-free solid dispersion1.
The oral route of drug administration is more common and convenient where tablets
and capsules emerged as popular dosage form but many patients have dysphagia or difficulty in
swallowing which is currently affecting 35% general population. From this perspective Quick
dissolving oral films offer a new and novel drug delivery system.
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6.2 Review of Literature:
A thorough literature survey on the topic has been done and very prominent are.
Development of nimodipine complex with and hydroxyl propyl cyclodextrein were tried to
enhance the solubility of the drug. The solubility and dissolution rate of nimodipine were markedly
enhanced by complexazation with -cyclodextrein and Hydroxy propyl -cyclodextrin needed
complexes gave higher dissolution rate than co evaporation method.5
The design and evaluation of Hydroxy propyl -cyclodextrin with camptothecin was done to
enhance the solubility and dissolution rate the solubility of camptothecin found to increase with both
increase in PH and Hydroxy propyl -cyclodextrein concentration.6
The development of celecoxib complexes was done to enhance the inclusion complex, the
solubility and dissolution rate of celecoxib were increased. The solid inclusion complex of celecoxib
and CD were prepared by the kneading method using different molar proportions of CD.
Enhancement of dissolution rate with increasing quantity of CD in the complex was observed. It was
also observed that the complexes exhibit higher dissolution rate than the pure drug and physical
mixture.7
An attempt was made to improve the in vitro dissolution behavior of Roficoxib cyclodextrin
inclusion complexes thus enhancing its dissolution rate, their by lading to a faster onset of action and
less G I mucosal toxicity. The inclusion complex found to have improved in vitro drug release compared
with a pure drug it was also found that a significant decrease in the gastric ulcerogenic activity of the in
the complex form.8
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The fast dissolving edible film composition comprising a safe and
effective amount of a cellulose based film forming agent comprising a mixture
of atleast one low viscosity cellulose based film forming agent; where in the
film composition rapidly dissolves in the oral cavity. In one embodiment the
edible film is a breath freshening film11.
Complexation of Glimepiride with HP-cyclodextrein has been reported, but no work has been
reported by microwave irradiation techinique. So it is planed to prepare the complexation by microwave
irradiatio technique and compare the complexes prepared by physical mixture. Further the complex is
formulated into Fast Dissolving Tablets (FDT) by Direct Compression Technique using Super-
disintegrants like Crosscarmelose Sodium, Crospovidone and Sodium Starch Glycolate.
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7. 7 MATERIALS AND METHODS:
It is mainly laboratory based methed.All the basic facilities required are available
in our college laboratories.
The survey of literature on the area of present investigation will be done by
referring to pharmaceutics abstracts, all the national and international journals.
The information about formulation and evaluation parameters will be collected by
referring to Indian journal of pharmaceutical science, Indian journal of
pharmaceutical education, European journal of pharmaceutical science, Indian
drugs, etc.
The day to day development in the area will be updated by literature survey
through e-publishing and internet. For this purpose, the library and internet facility
are available in our college.
For the drug dissolution studies, dissolution test apparatus USPXXIV is used. For
the estimation of drug UV-Visible spectrophotometer is used. For compatibility
studies IR spectrophotometer is used.
All the above facilities are availability in our college.
Preformulation study like phase solubility, stability constant are performed for
complexes.
Drug content uniformity will be known by performing assay of the prepared
formulations using UV-visible spectrophotometer method at 236nm.
Compatibility studies between drug & HPCD will be carried out by IR
spectroscopy.
Drug release data of Complexes will be obtained by performing in vitro
dissolution studies using USP dissolution apparatus type II with 500ml and water
as dissolution medium at 370 C and 50 rpm.
Aqueous solubility and partition co- efficient of the complexes will be conducted.
Characterization of the complexes (DSC, XRD, SEM, etc.,) will be get it done
from the institutions where the facilities available.
Statistical analysis of data obtained from the results.
Stability studies are performed for formulation as per ICH guidelines.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
--------Not applicable------------
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8. LIST OF REFERENCES:
6) Ann MS, Nguyen BN, Annectte BB. & Martin B. Effect of Hydroxy propyl -
cyclodextrin complexation and PH on solubility of Camtothecin Int J pharmaceutics
2004; Vol 284, 1-2: 61-68.
10) Deelip Derle, Sai Hanuman Sagar Boddu and Manoj Magar Studies of the
preparation,characterization and solubility of -Cyclodextrin inclusion complexes:
Indian j. Pharm.
Educes. Res. 40(4) Dec 2006
11) Ann AI, Rossman JM, Mark LK. Rapidly dissolving edible film compositions with
cellulose film forming polymers. US Patent 2004 Oct 14.
12) Kulkarni N, Sorg AF, Kumar LD. Fast dissolving orally combustable films. US
Patent 2008 Jan 24.
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Signature of the candidate
9.
(MOHAMMED UBAIDULLAH)
11.1 Guide
AJAYKUMAR PATIL
Asst. Prof.
Karnataka college of pharmacy
Bidar-585403.
11.2 Signature
13.2 Signature
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