“FORMULATION AND IN-VITRO EVALUATION OF FAST DISSOLVING TABLETS OFCEFIXIME”
M. Pharm. Dissertation Protocol Submitted to
Rajiv Gandhi University of Health Sciences, Bangalore
Karnataka
By
Mr.S.SRIKANTH.B.Pharm.
Under the Guidance of
MR. SATHEESH KUMAR.N
Senior Lecturer
DEPARTMENT OF PHARMACEUTICS
EAST WEST COLLEGE OF PHARMACY
BANGALORE–560091
2011-2013
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of candidate and address (In Block Letters) / SRIKANTH SURYAVAMSHI,#4-2-124/2,VIGNANPURI COLONY,
TANDUR, RANGAREDDY DISTRICT,
ANDHRA PRADESH.
PIN CODE:501141.
2 / Name of the Institute / EAST WEST COLLEGE OF PHARMACY, BANGALORE-560 091
3 / Course of study and subject: / M.PHARM. PHARMACEUTICS.
4 / Date of admission of course: / 8/12/2011
5 / Title of the topic:
“FORMULATION AND IN-VITRO EVALUATION OF FAST DISSOLVING TABLETS OF CEFIXIME”
6 / Brief Resume of this intended work:
6.1 Need for the study Enclosure-I
6.2 Review of Literature Enclosure-II
6.3 Objectives of study Enclosure-III
7 / Materials and Methods:
7.1 Source of data Enclosure-IV
7.2 Method of collection of data (Including sampling procedure, if any)
Enclosure-V
7.3 Does the study require any investigation or interventions to be conducted on patients of humans or animals? If so, please describe briefly.
------NO------
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
------NOT APPLICABLE------
8 / List of References Enclosure-VI
9 / Signature of the candidate / SRIKANTH SURYAVAMSHI
10 / Remarks of the Guide / The proposed research work is recommended for registration and approval
11 / Name and designation of (in block letters)
11.1 Guide
11.2 Signature / MR. SATHEESH KUMAR. N
SENIOR LECTURER
DEPT. OF PHARMACEUTICS,
EAST WEST COLLEGE OF PHARMACY,
BANGALORE-560 091.
11.3 Co-Guide (if any)
11.4 Signature / ------
------
11.5 Head of Department
11.6 Signature /
Dr. VENKATARAJU. M.P
PROFESSORHOD,
DEPT. OF PHARMACEUTICS,
EAST WEST COLLEGE OF PHARMACY,
BANGALORE-560 091.
12 / 12.1 Remarks of the Chairman / Principal
12.2 Signature / Prof. K. A. SRIDHAR
PRINCIPAL,
EAST WEST COLLEGE OF PHARMACY,
BANGALORE-560 091
ENCLOSURE-I
6) Brief resume of the intended work:
6.1) Need for the study:
Tonsillitis is an inflammation of the tonsils, the fleshy clusters of tissue on both sides of the back of the throat. The tonsils become enlarged and have a yellow or white coating. Pharyngitis is an inflammation caused by swelling of the pharynx between the tonsils and the voice box(larynx).1
Oral route is the most important and preferable route of administration for solid dosage forms. Tablets are the most common solid dosage forms, administered orally. Fast dissolving tablets are disintegrating and/or dissolve rapidly in saliva without the need for water. Fast dissolving tablets were formulated for pediatric, geriatric and bedridden patients.2
Cefixime is an antibiotic drug and belongs to third generation cephalosporin.It is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillin’s and some cephalosporins due to the presence of beta-lactamases may be susceptible to cefixime. It has molecular weight of 453.45gms/mol and chemical formula C16H15N5O7S2, IUPAC name (6R, 7R)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetamido]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. It has a half life of four hours.3
The fast dissolving tablets will enhance the clinical effect of the drug through pre gastric absorption from the mouth, pharynx and oesophagus by avoiding first pass metabolism. The fast dissolving tablets are formulated for many elderly persons who have difficulties in taking conventional oral dosage forms because of hand tremors and dysphagia.4
The objective and aim of the current study is to formulate and develop fast dissolving tablets of cefixime,in-vitro evaluation of formulated tablets,and to minimize the disintegration time by using superdisintegrants.
ENCLOSURE-II
6.2) Review of literature:
SatyanarayanaTet al., formulated and evaluated cefixime trihydrate oral disintegrating tablet’s using different concentrations of super disintegrating agents like croscarmellose sodium, sodium starch glycolate. Tablets were prepared by direct compression method. Oral disintegrating tablets had emerged as an alternative to the conventional oral dosage forms to improve the patient compliance. As the paediatric and geriatric patients had complained about the swallowing of conventional oral solid dosage forms, it became necessary to develop a dosage form which is patient friendly.5
Raghavendra rao NG et al., developed novel co-processed superdisintegrants by solvent evaporation method by using crospovidone and starch glycolate in different ratios (1:1, 1:2, and 1:3) for use in the fast dissolving tablet formulations. Fast dissolving tablets of felodipine were prepared by using the above co-processed superdisintegrants and evaluated for pre-compression and post-compression parameters. Effect of co-processed superdisintegrants on wetting time, disintegrating time, drug content, in-vitro release have been studied. It was concluded that dissolution rate of felodipine could be enhanced by coating the tablets with co-processed superdisintegrants.6
Raghavendra rao NGet al. designed fast dissolving tablets of nimodipine by direct compression technique with β-cyclodextrin complexes using various superdisintegrants. The powder blends were subjected for post-compression parameters. The prepared tablets were characterized by Digital scanning colourimetry (DSC) and FTIR studies. No chemical interaction between drug and excepients was confirmed by DSC and FTIR studies. The values of pre-compression parameters evaluated were within prescribed limits and indicated good free flowing property.7
Basawaraj patil Set al., designed and developed fast dissolving tablets of tizanidine hydro chloride by direct compression method. Formulations were evaluated for pre-compressional parameters as well as post-compressional parameters. The prepared tablets were characterized by FTIR studies. It was concluded that FDT could be prepared by direct compression method using different superdisintegrants enhanced dissolution will lead to improved bioavailability, improved effectiveness of tizanidine hydrochloride.8
Peter Cet al., designed fast dispersibleibuprofen tablets which disintegrate either rapidly in water, to form a stabilized suspension, or disperse instantaneously in the mouth to be swallowed without the aid of water. A direct compression method was used to prepare these two types of tablets containing coated Ibuprofen as a high dosed model drug. The selected tablet formulation, containing 26% galactomannan and 5% crospovidone, initiated disintegration before the galactomannan begun to swell. These tablets disperse in water with in 40 s and show a crushing strength of 95N.9
Birajuet al., investigated and developed the fast dissolving tablets of glipizide by direct compression method with a view to enhance patient compliance. Many patients expressed difficulty in swallowing tablets and hard gelatin capsules, resulting in non-compliance and ineffective therapy. Recent advances in novel drug delivery systems aimed to enhance safety and efficacy of drug molecules by formulating a convenient dosage form for administration and to achieve better patient compliance. One such approach led to development of fast dissolving tablet.10
Shaileshet al., investigated to optimize and formulate promethazine theoclate fast dissolving tablets that offer a suitable approach to the treatment of nausea and vomiting. The solubility of theoclate was increased by formulating it as a fast dissolving tablet containing β-cyclodextrin, crospovidone and camphor, using direct compression method. The optimization study involved multiple regression analysis and revealed that optimum amounts of camphor, crospovidone and β-cyclodextrin gave a rapidly disintegrating/dissolving tablet.11
Bhavesh Jet al., designed fast disintegrating tablet of diclofenac sodium. It was extensively used asan Non steroidal anti inflammatory drugs (NSAIDS); employed in the treatment of rheumatoid arthritis and osteoarthritis, affords quick relief of pain and wound oedema. Conventional tablet and hard gelatin capsule dosage forms posses higher disintegration time so patients obtain pharmacological effect after 30 to 45 minutes of dosage form administration that may result in high incidence of patient compliance and variable bioavailability. Fast disintegrating tablets were gaining prominence as new drug delivery systems. These dosage forms had shown disintegration within a minute with very less quantity of water.12
Tejviret al., aimed at novel drug delivery systems, tablets were most widely accepted dosage forms. Yet, dysphagiawas the most common disadvantage of conventional tablets. This was seen to afflict nearly 35% of the general population, to overcome such problems, certain innovative drug delivery systems, like ‘mouth dissolving tablets’ (MDT) have been developed. These are novel dosage forms which dissolved in saliva within few seconds, when placed on tongue. Such MDT’s could be administered without the need of water and are thus quite suitable for children, elderly and mentally disabled patients.13
Katsuhideet al., prepared a rapidly disintegrating tablets containing glycine and carboxymethylcellulose. Effect of disintegrant on the disintegration behaviour of the tablet in the oral cavity was evaluated. Wetting time of tablet prepared from carboxymethylcellulose having the hardness of 4 kg was 3 s. Tablet containing NS-300 showed fastest disintegration compared to other formulations.These results suggested that NS-300 possessed excellent wetting nature and resulted in the rapid disintegration of tablet. It was suggested that the tablet formulation containing NS-300 and glycine was highly applicable to water-insoluble drug, such as ethenzamide.14
ENCLOSURE-III
6.3) Objective of the study:
The current study will be carried out with the following objectives:
To bring out the fast dissolving tablets for the treatment of tonsillitis.
To prepare and evaluate fast dissolving tablets of cefixime.
To study the drug and polymer compatability.
To minimize the disintegration time by using superdisintegrants.
To investigate pre-compressionalproperties for granules
To evaluate post-compressional parameters of the developed formulations.
To determine the in-vitro drugrelease studies.
ENCLOSURE-IV
7) Materials and Methods:
Materials:
Drug: Cefixime
Polymers and Excepients: hydroxypropyl methylcellulose (HPMC), starch, Dibasic calcium phosphate (DCP), cross povidone, Micro crystalline cellulose-102, Aerosil or any other suitable polymer and excepients, will be used for the preparation of fast dissolving tablets during the course of study.
Methods of preparation:
Preparation of FDTs containing Cefixime drug with different excepients will be carried out by using either of one of the following method:
- Wet granulation method
- Dry granulation method
- Direct compression method
- Spray drying method or any other appropriate method.
7.1) Source of data:
Data is collected from:
- Textbooks and reference books.
- International and Indian journals.
- Research publications.
- Presentations like pharmaceutical poster presentation.
- Science Direct & other internet facilities.
- RGUHS Library
ENCLOSURE-V
7.2) Method of collection of data:
To study drug and polymer compatability
To evaluate pre-compression and post compression parameters for granules
Pre-compression parameters
- Angle of repose
- Bulk density
- Tapped density
- Carr’s index
Post-compression parameters
- Weight variation
- Thickness
- Hardness
- Swelling index
- Drug content
To study the drug polymer interaction by FTIR.
To carry out in-vitro drug release studies for the prepared formulations.
ENCLOSURE- VI
8) List of references:
- Sharma Vijay, Singh L, Saxena P, Kumar J, Ashok. Formulation and evaluation of mouth dissolve tablets of cefixime. Int Res J Pharm 2011;2(5):171-174.
- Debjit Bhowmik, Chiranjib B, Krishnakanth, Pankaj, Margret RC. Fast dissolving tablet: An overview. J Chem Pharm Res 2009;1(1):163-177.
- Satyanarayana T, Sravanthi M, Suresh PK, Navaneetha SK, Shaji G. Formulation and evaluation of cefixime trihydrate oral disintegrating agents. Int J Pharm Sci 2012;4(1):545-549.
- Raghavendra Rao NG, Upendra K. Formulation and design of fast dissolving tablets of felodipine using novel co-processed superdisintegrants. Int J Pharm Res 2010;2(9):113-121.
- Raghavendra Rao NG, Subhan MD. Formulation and evaluation of nimodipine fast dissolving tablets prepared with a complex by direct compression method. Am J Pharm Res 2011;1(2):49-65.
- Baswaraj Patil S, Upendra K, Arun BK, Srinivas R, Soodam. Formulation and evaluation of fast dissolving tablets of tizanidine hydrochloride by direct compression method. J Pharm Sci Res 2011;1(1):71-77.
- Peter Christian Schmidt, Simone S.Fast dispersible ibuprofen tablets. Euro J PharmSci2002;295-305.
- Biraju Patel, Dhaval P, Ramesh P, Chirag P, Serasiya T, Sanja SD. Development and in-vitro evaluation of fast dissolving tablets of glipizide. Int J Pharm Sci 2009;1(1):145-150.
- Shailesh Sharma, Neelam S, Ghanshyam D. Formulation of fast-dissolving tablets of promethazine theoclate. Trop J Pharm Res 2010;9(5):489-497.
- Bhavesh Vaghela J, Nayana MB, Nimish LP, Ajay RH, Altaf AD. Formulation and evaluation of fast disintegrating tablet of diclofenac sodium. Int J Pharm Res 2011;3(6):17-22.
- Tejvir Kaur, Bhawandeep G, Sandeep K, Gupta GD. Mouth dissolving tablets: A novel approach to drug delivery. Int J Pharm Res 2011;3(1):1-7.
- Katsuhide Terada, Jinichi F, Etsuo Y, Yasuo Y. Evaluation of rapidly disintegrating tablets containing glycerine and carboxymethylcellulose. Int J Pharm 2006;101-109.
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