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TRANSCRIPT
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
M. PHARM SYNOPSIS
YEAR 15/05/2010
TITLE OF THE SYNOPSIS
FORMULATION AND EVALUATION OF METHOTREXATE DOSAGE FORM FOR COLON SPECIFIC DRUG DELIVERY
BY
ASHIF ANJUKANDAN M.PHARM, PART- I
DEPARTMENT OF PHARMACEUTICS,
UNDER THE GUIDANCE OF
Mrs. SELVI ARUN KUMAR M. Pharm
Asst. Professor
DEPARTMENT OF PHARMACEUTICS
INSTITUTION GAUTHAM COLLEGE OF PHARMACY
R. T. NAGAR, BANGALORE-32, KARNATAKA
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF THE CANDIDATE
AND ADDRESS
Mr. ASHIF ANJUKANDAN
DEPARTMENT OF PHARMACEUTICS,
GAUTHAM COLLEGE OF PHARMACY,
SULTAN PALAYA, R.T NAGAR (PO)
BENGALURU – 32, KARNATAKA.
PERMANENT ADRESS
S/o ABDUL AZEEZ A.K.
ANJUKANDAN HOUSE
VALIYORA (P.O), 676304 (Pin)
VENGARA, MALAPPURAM (Dist).
KERALA.
2.NAME OF THE INSTITUTION DEPARTMENT OF PHARMACEUTICS,
GAUTHAM COLLEGE OF PHARMACY,
SULTAN PALAYA, R.T NAGAR (PO)
BENGALURU – 32, KARNATAKA.
3. COURSE OF STUDY AND
SUBJECT
MASTER OF PHARMACY IN
PHARMACEUTICS
4.
DATE OF ADMISSION TO
COURSE 15/05/2010
5. TITLE OF THE TOPIC “FORMULATION AND EVALUATION OF
METHOTREXATE DOSAGE FORM FOR COLON
SPECIFIC DRUG DELIVERY”
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
The word new or novel in the relation to drug delivery system is a search for something out of
necessity. An appropriately designed sustained or controlled release drug delivery system can
be major – advance towards solving the problem associated with the existing drug delivery
systems.1
Colon-specific drug delivery system has gained increased importance not just for the delivery
of the drugs for treatment of local diseases associated with the colon but also for its potential
for the delivery of proteins and therapeutic peptides. The following different categories of
drugs which require local delivery are suitable for colon drug delivery:
Drugs to treat irritable bowel syndrome. e.g. Sulfasalazine, steroids like
Fludrocortisones.
Drugs to treat colonic cancer require local delivery e.g. 5-Fluorouracil, Methotrexate.
Protein and peptide drugs - eliminating drug degradation e.g. Growth hormones,
Calcitonin,
To treat infectious diseases (amoebiasis & helminthiasis) - e.g. Metronidazole,
To treat Rheumatoid arthritis (NSAIDS), Nocturnal asthma, Angina require delay in
absorption due to Circadian rhythms.
Drugs showing more selective absorption in colon than small intestine due to small
extent of paracellular transport e.g. Glibenclamide, Diclofencac, Theophylline, Metoprolol,. 2
The various strategies for targeting orally administered drugs to the colon include covalent
linkage of a drug with a carrier, coating with pH-sensitive polymers, formulation of timed
released systems, exploitation of carriers that are degraded specifically by colonic bacteria,
bioadhesive systems and osmotic controlled drug delivery systems. 3
Cancer of the colon and rectum is one of the most common internal malignancies. Colorectal
cancer is the second-leading cause of cancer deaths in the United States. In 2005, estimated 1,
45290 new cases of colon cancer were diagnosed in the United States. Almost all cases of
colorectal cancer begin with the development of benign or noncancerous polyps. When colon
cancer cells spread outside the colon or rectum to lymph nodes, they may also spread to other
lymph nodes, the liver, or other organs. Surgery is still a mainstay of the treatment of
colorectal cancer. 4
Chemotherapy is also used to treat advanced colorectal cancer. But conventional
chemotherapy is not as effective in colorectal cancer as it is in other cancers, as the drug does
not reach the target site in effective concentrations. Thus, effective treatment demands
increased dose size, which may lead to undue consequences. To improve this situation,
pharmaceutical technologists have been working on ways to deliver the drug more efficiently
to the colon, where it can target the tumor tissues. It is possible that delivery of small
quantities of antineoplastic agent to the inner surface of the colon could destroy small tumors
that arise spontaneously in this region, reducing the need for surgery.4
Various approaches, namely microcapsules, compressed microcapsules, and modified tablets
can be used for the colon specific drug delivery.8
Methotrexate ((2S)-2-[(4-{[(2,4-Diaminopteridin-6-yl)methyl](methyl)amino} phenyl)
formamido] pentanedioic acid), is an antimetabolite and antifolate drug used in treatment of
cancer, autoimmune diseases and as an abortifacient in the induction of medical abortions. It
acts by inhibiting the metabolism of folic acid. It’s used in treatment of Chron’s disease and
colorectal cancer. It is also used as Antirheumatic Agents, Immunosuppressive Agents,
Dermatologic Agents, Antimetabolite.
Methotrexate competitively inhibits dihydrofolate reductase (DHFR), an enzyme that
participates in the tetrahydrofolate synthesis.5 Dihydrofolate reductase catalyses the
conversion of Dihydrofolate to the active Tetrahydrofolate. Folic acid is needed for the de
novo synthesis of the nucleoside thymidine so inhibits the synthesis of DNA, RNA,
thymidylates, and proteins.
Methotrexate is weak dicarboxylic acid with pKa of 4.8 to 5.5, thus it is mostly ionized at
physiological pH and oral absorption is saturated & dose dependent. A mean oral
bioavailability of about 33% and mean intra muscular bioavailability is 76%. Methotrexate is
metabolized by intestinal bacteria to the inactive metabolite 4-amino-4 deoxy-N-
methylpteroic acid (DAMPA) and account for less than 5% loss of oral dose. 6
The aim of this work is to design a Colon Specific Dosage form of Methotrexate.
Physicochemical properties and half life of Methotrexate makes its suitable candidate for
colonic drug delivery system .The site specific drug delivery of Methotrexate in this
formulation reduces the adverse effects and fluctuation in plasma concentration.
6.2 REVIEW OF LITERATURE
Literature review for undertaking the study was done by referring to various national and
international journals, published articles in various official standard books and referring to
various websites on the internet.
M.NAJMUDDIN et al.,1 Prepared Flurbiprofen microcapsules by solvent evaporation
method using Eudragit L‐100 and Eudragit S‐100 mixture [1:2, 1:3, 1:4, 1:5] were used as
pH‐sensitive polymers and evaluated for various physicochemical parameters such as particle
size, percentage yield, incorporation efficiency, drug polymer compatibility (IR study),
scanning electron microscopy (SCM) and drug release of microcapsule (pH 6.8) for 12 hrs.
Result shows that as the concentration of polymer increases it affects the particle size,
percentage yield and drug release of micro capsules. Results of this study suggest that
Flurbiprofen microcapsules can be successfully designed to develop sustained drug delivery,
which can improve compliance by reducing dosing frequency.
R. Saraswathi et al.,7 Developed and evaluated Albendazole microcapsules for colon-
specific delivery for better treatment of Helminthiasis, Filariasis, and colorectal cancer by
avoiding the side effects. Microcapsules prepared by the use of different concentrations of
sodium alginate and guar gum and studied for entrapment efficiency, surface morphology
and particle size analysis. In vitro drug release study in presence and absence of cecal content
were also studied. The particle size range is maximum for microcapsules with high
concentration of sodium alginate and guar gum. The results of in vitro release study indicated
that the amount of drug release decreased significantly with an increase in guar gum
concentration but it was reverse with respect to sodium alginate concentration.
D. Nagasamy Venkatesh et al.,8 Developed Tegaserod maleate colon specific drug delivery
systems via the oral route for irritable bowel syndrome, using Eudragit L 100 and S100
mixture (1:1, 1:2, and 1:3) as pH-sensitive polymers. Various approaches, namely
microcapsules, compressed microcapsules, and modified tablets were made for this study. The
microcapsules were prepared by the emulsion-solvent evaporation method using drug and
mixture of polymers and evaluated for various physicochemical parameters such as particle
size, surface morphology, drug loading capacity, and in vitro dissolution studies by half-
dilution method employing various pH environments (pH 1.2-6.8) for 24 hours. The batch
prepared using the 1:2 drug polymer ratio was selected as an ideal batch for compression to
get the compressed tablet of the microcapsules. The modified tablets were also prepared using
the drug with hydroxylpropylmethylcellulose as the inner material and ethyl cellulose as the
outer material employing the double compression technique. Comparisons of microcapsules,
compressed microcapsules, and modified tablets containing tegaserod maleate indicated that
the drug release profiles from the microcapsules were found to be better than the compressed
microcapsules and the modified tablets in the colonic environment.
Mohini Chaurasia et al.,9 Prepared and characterized guar gum microspheres containing
methotrexate (MTX) for local release of drug in the colon, which is a prerequisite for the
effective treatment of colorectal cancer. Guar gum microspheres were prepared by the
emulsification method using glutaraldehyde as a cross-linking agent. Microsphere were
evaluated particle size, shape, and surface morphology. MTX-loaded microspheres
demonstrated high entrapment efficiency. The in vitro drug release was investigated using a
US Pharmacopeia paddle type (type II) dissolution rate test apparatus in different media
(phosphate-buffered saline [PBS], gastrointestinal fluid of different pH, and rat cecal content
release medium), which was found to be affected by a change to the guar gum concentration
and glutaraldehyde concentration.
Lanjhiyana Sanjay Kumar and Dangi Jawahar Singh.,10 Developed pulsatile release
based enteric coated capsules for site specific delivery of Methotrexate to colon. The modified
formulation was capable of delaying onset of drug release for a programmed lag time period
of 3-5 h in the simulated physiological environment of upper gastrointestinal tracts depends
on coating ratios of HPMC (inner coating) and Eudragit-S100 (outer coating). Dissolution
studies demonstrates that, polymeric coated formulations of HPMC and pH sensitive
Eudragit-S 100 were gastro-resistance for 2 h at pH 1.2 and further for 3 h at pH 6.8, since
they released only 3-7 % of drug in physiological environment of stomach and small intestine.
The complete disintegration occurred only after a certain lag time of 4 to 5 h. DSC
thermogram analysis shows no possibility of interaction between drug and polymers used in
the study. The study result demonstrated that the developed system can be a promising device
for targeting of methotrexate to colonic region for treatment of colorectal cancer
Parul Trivedi et al.,11 Developed formulation where in Aceclofenac is microencapsulated
with Eudragit (S 100, RL 100, and RS 100), using an O/W emulsion-solvent evaporation
technique and evaluated micromeritic properties including angle of repose, bulk density,
tapped density, Carr's Index, Hausner's ratio, and particle size determination and also drug
loading, in vitro drug release as well as for scanning electron microscopy. In vitro drug
release studies were carried out up to 24 h in three different pH media, i.e., 0.1 N HCl (pH
1.2), phosphate buffer (pH 6.8), and phosphate buffer (pH 7.4).
Wu Ping et al.,12 Developed a chitosan-methotrexate covalently conjugated nanoparticles
(CS-MTX-TPP NPs) as a potential delivery system for Methotrexate (MTX). MTX was first
conjugated to CS by using Glutaraldehyde as cross-linked agent, and followed by the process
of ionic gelation between MTX-conjugated CS and Sodium Tripolyphosphate (TPP) to form
CS-MTX-TPP NPs at mild reaction conditions. Nanoparticles evaluated for the encapsulation
efficiency of MTX. The characterizations by Atomic Force Microscopy and Photon
Correlation Spectroscopy showed the CS-MTX-TPP NPs had a spherical shape and good
dispersion with diameter of sub-200-nm and zeta potential of 30 mV. Additionally, in vitro
release test revealed that the stable covalent bonding of CS and MTX was beneficial for
providing slow release for MTX.
Mukesh Ukawala et al.,13 Formulated and characterized calcium phosphate nanoparticle
containing anticancer drug, Methotrexate (MTX). Calcium Phosphate nanoparticles
containing MTX (CaPi-MTX) were prepared by reverse micelles technique and evaluated
average size and entrapment efficiency. The IR spectrum of CaPi-MTX showed
characteristics of composite formation of hydroxyapatite with MTX. X-RD analysis revealed
that, CaPi-MTX nanoparticles were crystalline and in hydroxyapatite form. TEM studies
showed that CaPi-MTX nanoparticles were spherical in shape. In vitro release study of CaPi-
MTX nanoparticles showed slow release of MTX at physiological pH (pH 7.4) while >90%
release was observed within 3-4 hours at endosomal pH (pH 5.5 and pH 6.0). Confocal
microscopy was performed using CHO cell lines, showed intracellular localization of FITC-
Dextran loaded calcium phosphate nanoparticles. Results indicate that prepared CaPi-MTX
nanoparticles could serve the purpose for intracellular drug delivery.
M. Chaurasia et al.,14 Prepared calcium pectinate (Ca-pectinate) microspheres to deliver
methotrexate in the environment of colon by modified emulsification method using calcium
chloride as cross linker. All the formulations were evaluated for various physicochemical
parameters like Particle size of the microspheres, Encapsulation efficiency and in vitro drug
release studies were performed in simulated gastric fluid for 2 hours and simulated intestinal
fluid for 3 hours. In vitro release rate studies were also carried out in simulated colonic fluid
in presence of rat caecal contents. Moreover, release rate studies were also carried out after
enzyme induction by treating the rats with 1 ml of 1% w/v aqueous dispersion of pectin for 7
days. This study concluded that calcium pectinate microspheres can be used to effectively
localize the release of drug in the physiological environment of colon.
Ziyaur Rahman et al.,15 Prepared and evaluated the colon-specific microspheres of 5-
Fluorouracil for the treatment of colon cancer. Core microspheres of alginate were prepared
by the modified emulsification method in liquid paraffin and by cross-linking with calcium
chloride and were coated with Eudragit S-100 by the solvent evaporation technique to prevent
drug release in the stomach and small intestine. The microspheres were characterized by
shape, size, surface morphology, size distribution, incorporation efficiency and In vitro drug
release studies. Release was sustained for up to 20 hours in formulations with core
microspheres to a Eudragit S-100 coat ratio of 1:7, and there were no changes in the size,
shape, drug content, differential scanning calorimetry thermogram, and In vitro drug release
after storage at 40°C/75% relative humidity for 6 months.
V.S. Mastiholimath et al.,16 Investigated an oral colon specific, pulsatile device to achieve
time and/or site specific release of Theophylline, based on chronopharmaceutical
consideration. They filled Eudragit microcapsules of Theophylline insoluble hard gelatin
capsule body and sealed with a hydrogel plug. The entire device was enteric coated to
overcome the variability in gastric emptying time and to achieve a colon-specific release .
Microcapsules were prepared in four batches, with Eudragit L-100 and S-100 (1:2) by varying
drug to polymer ratio and evaluated for the particle size, drug content and In vitro release
profile and from the obtained results; one better formulation was selected for further
fabrication of pulsatile capsule. Different hydrogel polymers were used as plugs, to maintain a
suitable lag period and it was found that the drug release was controlled by the proportion of
polymers used. In vitro release studies of pulsatile device revealed that, increasing the
hydrophilic polymer content resulted in delayed release of Theophylline from microcapsules.
The gamma scintigraphic study pointed out the capability of the system to release drug in
lower parts of GIT after a programmed lag time for nocturnal asthma. Programmable
pulsatile, colon-specific release has been achieved from a capsule device over a 2–24 h
period, consistent with the demands of chronotherapeutic drug delivery.
S. K. Uma Devi et al.,17 Developed novel colon specific drug delivery systems for
Aceclofenac using pectin as a microbially degradable polymeric carrier and to coat the
optimized batches with a pH dependent polymeric coating solution containing Eudragit L 100
and S 100 (1:4). Pellets containing four proportions of pectin were prepared. The pellets were
evaluated for physicochemical properties, drug content, dissolution, water uptake & erosion
characteristics, In vitro drug release studies. The dissolution profile and in vitro release
kinetics showed that pectin pellets were promising for controlled delivery of the drug. The
findings of this study concluded that pectin pellets are promising for colon targeting of
Aceclofenac to synchronize the chronobiological symptoms for effective treatment of
Rheumatoid arthritis.
R.S.S. Shendge et al.,18 Prepared Colon targeted drug delivery system by using Dextrin,
polysaccharide, as a carrier for Aceclofenac matrix tablet by wet granulation technique .
Different binder like Ethyl cellulose, Sodium CMC and Sucrose were used during preparation
of matrix tablets containing dextrin and various excipients. Evaluation was done by different
IPQC tests, content uniformity and in vitro drug release study. Drug release profile was
evaluated in simulated gastric, intestinal fluid and simulated colonic fluid. The matrix tablet
containing binder system of ethyl cellulose and dextrin as a carrier was found to be suitable
for targeting the colon as compare to other matrix tablets containing different binders because
of fewer amounts of drug release in the simulated gastric and intestinal fluid.
P.B. Aswar et al.,19 Developed colon targeted matrix tablet of Diclofenac Sodium by using
various proportions of gaur gum as a carrier and Sodium-CMC, Sucrose 70% and Ethyl
cellulose as a binder by wet granulation technique. The prepared matrix tablets were
evaluated by different In-Process Quality Control tests like content uniformity and drug
release study and Drug release profile in simulated gastric fluid, intestinal fluid and simulated
colonic fluid. The matrix tablets containing gaur gum as a carrier and ethyl cellulose as a
binder was found to be suitable for targeting Diclofenac Sodium for local action in the colon
as compared to other matrix tablets containing different binders because of amount of drug
release in simulated gastric fluid and intestinal fluid.
6.3 OBJECTIVES OF THE STUDY1. Development of suitable dosage form based on the Preformulation studies
2. Evaluation of formulated Dosage form for following parameters.
i) Percentage yield
ii) Incorporation efficiency
iii) Particle Size
iv) Angle of Repose
v) Morphology and Surface Appearance
vi) Infrared Spectroscopy
vii) In – Vitro drug release.
7. MATERIALS AND METHODSDrug : Methotrexate
Polymer : Eudragit L100 or Eudragit S100, Eudragit RS 100, Eudragit RSPO,
Cellulose Acetate Phthalate, Shellac and Guar Gum.
Method :Solvent evaporation and other innovative techniques.
7.1 SOURCE OF DATA: Available published literatures
Lab experiment.
7.2 METHOD OF COLLECTION OF DATA: Data on drugs and polymers will be collected by literature survey.
Data on Preformulation and post formulation studies will be collected through
experimental and analytical methods.
7.3 Does the study require any investigations or invention to be conducted
on patients or other human or animals? If so, please mention briefly.NA
7.4 Has ethical clearance been obtained from your institution in case of 7.3? NA
8. REFERENCES
1. M. Najmuddin, Vishal Patel, Aejaz Ahmed, S. Shelar, T. Khan. “Preparation and
Evaluation of Flurbiprofen Microcapsules for Colonic Drug Delivery System”. Int. J.
Pharmacy Pharm. Sci. 2010; 2(2): 83-87.
2. Sateesh Kumar Vemula and Prabhakar Reddy Veerareddy. “Different approaches to
design and evaluation of colon specific drug delivery systems”. Int.J.Pharmacy and
Tech. 2009; 1 (1): 1-35.
3. M.K. Chourasia, S.K. Jain. “Pharmaceutical approaches to colon targeted drug
delivery systems”. J. Pharm. Pharm. Sci. 2003; 6(1): 33-66.
4. M. Chaurasia, M.K. Chourasia, N.K. Jain, A. Jain, V. Soni, Y.Gupta, S.K. Jain.
“Cross-Linked Guar Gum Microspheres: A Viable Approach for Improved Delivery
of Anticancer Drugs for the Treatment of Colorectal Cancer”. AAPS PharmSciTech.
2006; 7(3): Article 74.
5. P. T. Ravi Rajagopalan, Zhiquan Zhang, Lynn McCourt, Mary Dwyer, Stephen J.
Benkovic, and Gordon G. Hammes . "Interaction of dihydrofolate reductase with
methotrexate: Ensemble and single-molecule kinetics". PNAS. 99(21): 13481–13486.
6. Meyer. L.M., Miller F.R., Rowen M.J., Bock. G., Rutzky. J. (1950). "Treatment of
acute leukemia with amethopterin (4-amino, 10-methyl pteroyl glutamic acid)". Acta
Haematologica. 4 (3): 157–67.
7. R. Saraswathi, S.P.Simi, C.Sankar, P.N. Krishnan, C. Dilip, K. Ameena. “Guar gum
based microcapsules for colonic delivery of albendazole: Development and In-vitro
evaluation”. Res. J. Pharm. Biol. & Chem. Sci. 2010; 1(4): 373.
8. D. Nagasamy Venkatesh, Ajay Kumar Reddy, M.K. Samanta, B. Suresh.
“Development and in vitro evaluation of colonic drug delivery systems for Tegaserod
maleate”. Asian J. Pharmaceutics. 2009; 3 (1): 50-53.
9. M. Chaurasia, M.K. Chourasia, N.K. Jain, A. Jain, V. Soni, Y. Gupta, S.K. Jain.
“Cross-Linked Guar Gum Microspheres: A Viable Approach for Improved Delivery
of Anticancer Drugs for the Treatment of Colorectal Cancer”. AAPS PharmSciTech.
2006; 7(3): Article 74.
10. Lanjhiyana Sanjay Kumar and Dangi Jawahar Singh. “Development and In-Vitro Drug
Release Studies of Methotrexate from Modified Pulsatile Release Guar Gum based
Enteric Coated Capsules for Colon Specific Delivery”. Indian J.Pharm. Educ. Res.
2008; 42(2): 154-160.
11. P. Trivedi, A Verma, N. Garud. “Preparation and characterization of aceclofenac
microspheres”. Asian J. Pharmaceutics. 2008; 2: 110-115.
12. Wu Ping, He Xiaoxiao, Wang Kemin, Tan Weihong, He Chunmei, Zheng Mingbin.
“A Novel Methotrexate Delivery System Based on Chitosan-Methotrexate Covalently
Conjugated Nanoparticles”. J. Biomed. Nanotech. 2009; 5(5): 557-564.
13. Mukesh Ukawala, Kulkarni Vijay, Tushar Rajyaguru, R.S.R. Murthy. “Methotrexate
Loaded Self Stabilized Calcium Phosphate Nanoparticles: A Novel Inorganic Carrier
for Intracellular Drug Delivery”. J. Biomed. Nanotech. 2009; 5(1): 99-105.
14. M. Chaurasia, M. K. Chourasia, Nitin, K. Jain, A. Jain, V. Soni, Y. Gupta, S. K. Jain.
“Methotrexate bearing calcium pectinate microspheres: a platform to achieve colon-
specific drug release”. Curr. Drug Deliv. 2008; 5(3): 215-219.
15. Z. Rahman, K. Kohli, R.K. Khar, M. Ali, N.A. Charoo, A.A. Shamsher.
“Characterization of 5-Fluorouracil Microspheres for Colonic Delivery”. AAPS
PharmSciTech. 2006; 7(2): Article 47.
16. V. S. Mastiholimath, P. M. Dandagi, S. Samata Jain, A. P. Gadada and A. R. Kulkarni.
“Time and pH dependent colon specific, pulsatile delivery of Theophylline for
nocturnal asthma”. Int. J. Pharmaceutics. 2007; 328(1): 49-56.
17. S. K. Uma Devi, R. Thiruganesh and S. Suresh. “Preparation and characterization of
pectin pellets of Aceclofenac for colon targeted drug delivery”. J. Chem. Pharm. Res.
2010; 2(1): 361-374.
18. Raosaheb S. Shendge, Fatima J. Sayyad, Kishor S. Salunkhe and Rasika D. Bhalke.
“Development of Colon Specific drug delivery of Aceclofenac by using effective
binder system of ethyl cellulose”. Int. J. Pharma & BioSci. 2010; 1(3).
19. P. B. Aswar, S. S. Khadabadi, B. S. Kuchekar, T. P. Wane, N. Matake.
“Development and in-vitro evaluation of colon specific formulation for orally
administered Diclofenac Sodium”. Arch. Pharm. Sci. & Res. 2009; 1(1): 48-53.
9. Signature of Candidate
10. Remarks of the guide
The above information is true to the best of my knowledge and the work will be done under my guidance.
11. 11.1 Name and Designation of Guide Mrs. SELVI ARUN KUMAR. M.Pharm
Asst. Professor,
Department of Pharmaceutics,
Gautham College of Pharmacy,
Sultanpalaya, R.T Nagar (P.O)
Bangalore – 32, Karnataka.
11.2 Signature
11.3 Co-Guide (IF ANY)
11.4 Signature
11.5 Head of the Department Dr. SANJAY PRAHALAD UMACHIGI. M.Pharm, PhD.
Prof. & Head
Department of Pharmaceutics,
Gautham College of Pharmacy,
Sultanpalaya, R.T Nagar (P.O)
Bangalore – 32, Karnataka.
11.6 Signature
12. 12.1 Remarks of the Principal
The above mentioned information is correct and I recommend the same for approval.
12.2 Signature
Mrs. ARCHANA. P. SWAMY. M. Pharm,( PhD).
Principal
Gautham College of Pharmacy,
Sultanpalaya, R.T Nagar (P.O)
Bangalore – 32, Karnataka.