Design and Evaluation of Oro Dispersible Tablets of Promethazine by Using Natural Gum

“DESIGN AND EVALUATION OF ORO dispersible tablets of promethazine by USING natural GUM’S and MUcILAGES”

M.PHARM DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

By

ANURADHA C PATIL

Under the guidance of

MAHADEVAPPA.V.RAMPURE

M. Pharm

DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY

H.K.E.S’s COLLEGE OF PHARMACY

GULBARGA-585105

2010-11

1

RajivGandhiUniversity of Health ScienceS, Karnataka Bangalore

Annexure – II

Proforma for Registration of Subjects for Dissertation

1. / Name of the candidate
(In block letters) / anuradha c.patil
Permanent Address / 96,SHANTI NAGAR MSK MILL road,
Gulbarga – 585103
2. / Name of the Institution / H.K.E. Society’s College of
Pharmacy, Sedam Road,
Gulbarga - 585103
3. / Course of study and subject / M.Pharm
(PHARMACEUTICAL TECHNOLOGY)
4. / Date of admission to the course / 7/7/2010
5. / Title of the Topic / DESIGN AND EVALUATION OF ORODISPERSIBLE TABLETS OF PROMETHAZINE USING GUMS AND MUCILAGES
6. / Brief resume of the intended work
6.1 / Need for the study:
Oral route of drug administration is perhaps the most appealing route for the delivery of the drugs. The various dosage forms are administered orally, among them the tablet is one of the most preferred dosage forms because of its ease of manufacturing, convenience in administration, accurate dosing, stability compared with oral liquid and capsules. Orodispersable drug delivery is rapidly gaining acceptance as an important new drug delivery technology and their characteristics benefits in terms of patient compliance, rapid onset of action, increased bioavailability (sometimes bi-pass first pass effect) and good stability make these tablets popular as a dosage form of choice1.
Patients often experience inconvenience in swallowing conventional tablets when water is not available. Furthermore, patients who have swallowing problems encounter difficulties in taking tablets, particularly pediatric and geriatric patients. Such problems can be overcome by means of fast dissolving tablets. This tablet disintegrates oral disperses in the saliva passes down in the stomach. In such cases, bioavailability of drug is significantly greater than those observed from conventional dosage form2,3.
Usually, super disintegrants are added to drug formulation to facilitate the break-up or disintegration of tablet or capsule content into smaller particles that can dissolve more rapidly than in the absence of disintegrants like crosspovidone, croscarmellose sodium, sodium starch glycolate, microcrystalline cellulose. Similarly, various sophera linn seed natural gum, gum karaya, modified starch and cassia fistula linn seed have been used in the formulations of fast dissolving tablets. Mucilage of natural origin is preferred over semi-synthetic and synthetic substances because they are comparatively cheaper, abundantly available, non- irritating and non-toxic in nature4.
Hence, the aim of the present study is to develop low cost natural excipients,which can be used in the design of fast dissolving tablet(orodispersible tablet)using promethazine as an antihistaminicwhich is phenothiazine derivative, is an sedating antihistamine with antimuscuranic activity which is water soluble in half life is 5-14 hrs.
6.2 / Review of Literature
Literature review shows that no published report of any work on fast dissolving tablet of promethazine which is antihistamenic drug using gums and mucilage some of the published articles on similar works for various medicinal agents are done.
Jani KJ, shah PD and jain V et al, have reported that a wide variety of materials to help to improve and sustain thehealth of all the living things either directly or indirectly. In the recent years these have been of great importance and development in different dosage forms for existing and newly designed drugs and natural products and semisynthetic as well as synthetic excipients can be used for a variety of purposes. Gums and mucilages are widely used natural materials for conventional and novel dosage forms. These natural materials have advantages over synthetic ones science they are chemically inhert and nontoxic,less expensive and widely available they can be modified for different ways as tailor made materials which is used for the formulation of tablets and thus can compete with the synthetic excipients6.
SinghSK and Singh S have made an attempt to evaluate the suitability of cassia fistula seeds as tablet binder. The mucilages were evaluated for its granulating and binding properties in tablet using diltiazem hydrochloride as a model drug. All the formulations were subjected to stability studies for 3 months as per ICH guidelines all formulations showed stability with respect to release pattern and other parameters which confirm the use of mucilage as excipient7.
Rao NGR, Ketan T, bala S, have prepared the fast dissolving tablets of metoprolol tartarate by direct compression method using different concentrations of plantgo ovata mucilage as natural super disintegrant8.
Singh AK, Kumar V, Shingala R, Selvam P, Sivakumar T. have made an attempt to evaluate the gum of manigifera indica(mango)as a tablet binder employing paracetamol as a model drug. Natural gums are economic, easily available and found useful as tablet binder. The prepared tablet were evaluated for physicochemical properties. The friability of the tablets ranges from 1.12 to 0.26% and the disintegration time from 3 to 8 min. the binding efficiency of the manigifera indica gum was compared with the standard binder guar gum, at similar concentrations 5% w/w and hardness ranging from ranging from 6.3 to 6.8kg/cm2 which are compared with the standard gum and acacia9.
Shah V, Patel D, Manne S,Upadhya U. reported that in the present study examines the effect of guar gum(GG) and MGG was prepared using heat treatment method it was characterized for viscosity, swelling index and water retention capacity.
The physical and co grinding mixtures of licofelone with GG and MGG (modified guar gum) was prepared in the ratios of 1:6, it is characterized by DSC and FT-IR studies these confirmed and no interaction between drug and carrier and in vitro dissolution studies using USP apparatus10.
Kumar R, Patil S, PatilMB, Patil SR, Paschapur MS, have prepared mouth dissolving tablets formulation containing metformin hydrochloride mucilage extracted from fenugreek seeds , these were subjected to toxicity studies, The extracted mucilages are devoid of toxicity11.
Rani AP, Archana N, Teja PS, Vikas M, Kumar S, have made prepared the fast disintegrating tablet of metformin Hcl using isaphgol as a natural super disintegrant, and the prepared formulations were subjected for pre compression and post compression parameters based on the invitro dispersion time 10 sec. hence isaphgol husk was recommended as a suitable disintegrant for the prepration of FDT by direct compression method12.
Satyam G, Singh S, Garg G, Sharma N, Sharma PK, have prepared diclofenaic sodium tablet by wet granulation method by using 2%w/v, 4%w/v, 6%w/v, 10%w/v papaya starch as a binding agent (carica pappya)13.
6.3 / Objectives of the study
In the present work, studies will be carried out on the design and evaluation of fast dissolving tablets of promethazine. By using natural ingredients and gums and mucilages. The prepared tablets will be evaluated for hardness, friability, weight variation, disintegration time, drug content, invitro dissolution studies and drug recipient reaction(IR spectroscopy).
7. / Materials and Methods
7.1 / Materials used are gums and mucilages
7.2 / ISOLATION OF GUMS AND MUCILAGES
Plant material will be dried in sunlight or in an oven at 1050c to retain its properties unchanged. Generally, the chlorophyll or pigment which will be present in the plant material will be removed before isolating the mucilage. Plant material will be treated with petroleum ether or chloroform to remove pigments or chloroform, and then the plant material will be cleaned with the distilled water. Care should be taken while drying the final isolated product mucilage. It will be dried at very low temperature(not more than 50) or in a vaccum. The dried material will be carefully stored in desicator to prevent further moisture uptake or degradation.
The fresh plant material will be collected washed with water to remove dirt and debris, and dried. Then the material will be soaked in water for 5-6 hours boiled for 30min, and allowed to stand for 1hour so that all the mucilage will be released into water. The material will be then squeezed from muslin bag to remove the marc from the solution and filtered, further to the filtrate equal volumes of filtrate will be added to precipitate the mucilage. The mucilage will be separated. Dried in the hot air oven at a temperature less than 500c and will be dried and powered and passed under sieve no 80 and stored in a desicators until required time.
APPLICATIONS OF GUMS AND MUCILAGES
Gums and mucilages have a wide variety of applications in the pharmacy. They are usedin the medicine for their demulcent properties for cough, suppression.They are ingredients of dental and other adhesives and can be used as bulk laxatives, they are useful as tablet binders, disintegrants, emulsifiers, suspending agents, gelling agents, stabilizing agents and thickening agents etc.
Direct compression method:
In this method the drug is directly compressed with the super disintegrants such as natural gums, like Agar and guar gum, Acacia, tragacanth etc and binders, lubricants and this usually done to the drug which is in the granule form.
Sublimation: In this method, mannitol is used as a diluent and camphor as a volatile material. After compression, the tablets will be heated in hot air oven at 500 C until a constant weight is obtained ensure the complete removal of volatilizable component.
Effervescent technique:
In this method, mannitol is used as a diluents and sodium bicarbonate and citric acid as effervescent materialsto prepare tablets and mucilage like cassia tora linn, isaphgol mucilage and fenugreek in the tablet formulation as superdisintegrant.
Addition of disintegrant:
In this method, super disintegrants such as sodium starch glycolate, cross linked polymers, cross linked pvp, agar etc will be included to obtain disintegration.
Evaluation of orodispersible tablets:
Estimation of drug content: the drug content of orodispersible tablets will be determined spectrophotometrically on the filtered methanolic extracts of the drug.
Disintegration time:
disintegration time of orodispersable tablets will be determined by using distilled water
at 37±20c as a medium using tablet disintegration test apparatus BP
In vitro dissolution study:
In vitro drug release study of prepared fast dissolving tablets will be carried out in 900 ml of ph of 6.8 phosphate buffer in the usp XXII tablet dissolution tester.
8. / List of Reference

1. Sharma S, Singh G, Gupta GD. Formulation, design and optimization of mouth dissolving tablet of domperidone using sublimation technique. Inj Pharm Sci 2010; 1(1): 1280-36.
2. Masaki k, Academy of pharmaceutical science and technology kisarazel, Japan Tokyo, Japan 1997; pp 79-84.
3. Sreenivas SA, Gadad AP, Dondogi et al, Ind drugs 2006; 43(1): 35-38.
4. Chakraborty S, Khandai M, Satya PS, Niranjan CP. Comparative study on the effect of natural and synthetic super disintegrant in the formulation of fast dissolving tablets. Int J Green Pharm 2008; 2(1): 22-5.
5. SweetmanSC. The editor. Martindale : The complete drug reference 33rd edn, London: Pharmaceutical press 2007; p. 531.
6. Jani KJ, Shah DP, Prajapati VD, Jain VC. Gum and mucilages:versatile excipients for pharmaceutical formulation. Asian J Pharm Sci 2009; 4(5): 309-23.
7. SinghSK, Singh S. Evaluation of cassia fistula linn seed mucilage in tablet formulation. Int J PharmTech Res 2010; 2(3): 1839-46.
8. Rao NG, Ketan T, Bala S. Formulation and evaluation of fast dissolving tablets of metoprolol tartarate using natural super disintegrant. Int J Pharm Cli Res 2010; 2(1): 42-5.
9. Singh AP, Shingala VK, Selvam RP, Shivkumar T. Evaluation of mangifera indica gum as tablet binder. Int J PharmTech Res 2010; 2(3): 2098-100.
10. Shah V, Patil D, Mane S, Upadhyay U. Solubility and dissolution rate enhancement of licofelone by using modified guar gum. Int J PharmTech 2010; 2(3): 1847-54.
11. Kumar R, PatilMB, Patil SR, Paschapur gangwar S, Singh S, Garg G. Isolation and evaluation of binding property of papaya starch in diclofenac sodium tablet. Int J Pharm Res 2010; 2(2): 1508-12.
12. Rani AP, Archana N, Teja S, Vikas PM, Kumar MS, Sekaran CB. Formulation and evaluation of orodispersible metformin tablets. Int J Applied Pharm 2010; 2(3): 15-21.
13. Gangawar S, Singh S, Garg G, Sharma N, Sharma PK. Isolation and evaluation of binding property of papaya starch in diclofenac sodium tablet. Int J PharmTech Res 2010; 2(2): 1508-12.

9. / Signatures of candidate / ANURADHA C PATIL
10. / Remarks of Guide / Newer low cost directly compressible natural excipients will be cost effective in design and development of oral dispersible tablet formulation of Antihistamine drugs have definite advantages in improving the patient compliance and for administering the patients.
11. / Name and designation of
(in block letters)
11.1 Guide / M.V. RAMPURE
M. Pharm. (Ph.D)
ASST. PROFESSOR
DEPT.OF PHARMACEUTICAL TECHNOLOGY
H.K.E.SCOLLEGE OF PHARMACY,
GULBARGA-585105.
11.2 Signature
11.3 Co-guide / S.B.SHIRSAND
M. Pharm. (Ph.D)
PROFESSOR
DEPT.OF PHARMACEUTICAL TECHNOLOGY
H.K.E.SCOLLEGE OF PHARMACY, GULBARGA-585105.
11.4 Signature
11.5 Head of the Department / Dr. P.V SWAMY
M. Pharm. Ph.D
PROFESSOR
DEPT.OF PHARMACEUTICAL TECHNOLOGY
H.K.E.SCOLLEGE OF PHARMACY,
GULBARGA-585105.
11.6 Signature
12 / 12.1 Remarks of chairman and Principal
12.2 Signature

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