Development and Evluation of Poly Herbl Orodispersible Tablets Containing

Development and Evluation of Poly Herbl Orodispersible Tablets Containing

DEVELOPMENT AND EVALUATION OF POLYHERBAL ORODISPERSIBLE TABLETS CONTAINING

MOUTH FRESHNERS

M. Pharm. Dissertation Protocol Submitted to

RajivGandhiUniversity of Health Sciences, Karnataka

Bangalore – 560041

By

Mr.BHEEMSEN YENNI.B. Pharm.

Under the Guidance of

Shri. B.S. Patil,M. Pharm(Ph.D)

Asst. Professor

Post Graduate Department of Pharmacognosy,

SET’S College of Pharmacy,

S.R.Nagar, Dharwad,

Karnataka-580002.

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF THE CANDIDATE
AND ADDRESS / BHEEMSEN H YENNI
DEPT. OF PHARMACOGNOSY
SET’s COLLEGE OF PHARMACY
S.R.NAGAR,
DHARWAD-580002
2. / NAME OF THE INSTITUTION / SET’s COLLEGE OF PHARMACY
S. R. NAGAR,
DHARWAD-580002
3. / COURSE OF STUDY AND
SUBJECT / MASTER OF PHARMACY IN
PHARMACOGNOSY
4. / DATE OF ADMISSION TO
COURSE / 20-07-2011
5. / TITLE OF THE TOPIC “DEVELOPMENT AND EVALUATION OFPOLYHERBL ORODISPERSIBLE
TABLETS CONTAINING MOUTH FRESHNERS”
6.0
7.0 / BRIEF RESUME OF THE INTENDED WORK
6.1 INTRODUCTION :
The concept of fast dissolving drug delivery system emerged from the desire to provide patient with conventional mean of taking their medication. Fast dissolving orodispersible dosage forms can be disintegrated, dissolved, or suspended by saliva in the mouth. This fast dissolving tablet disintegrates instantaneously when placed on tongue and releases the drug dissolves or disperses in the saliva1.Orodispersible tablets are useful in patients2,3 like pediatric, geriatric, bedridden, or mentally disabled, who may face difficulty in swallowing conventional tablets or capsules4 leading to ineffective therapy5, with persistent nausea, sudden episodes of allergic attacks, or coughing for those who have an active life style. Fast dissolving tablets are also applicable when local action in the mouth is desirable such as local anesthetic for toothaches, oral ulcers, cold sores, or teething6, and to those who cannotswallow intact sustained action tablets/capsules7.
6.2 NEED FOR THE STUDY:
Despite of tremendous advancements in drug delivery the oral route remains the perfect administration of therapeutic agents because the low cost of therapy and ease of administration lead to high level of patient compliance. Patient convenience and compliance oriented research has resulted in bringing our safer and newer drug delivery systems.Recenly fast dissolving as well as orodispersible drug delivery systems started gaining popularity and acceptance as one such example with increased consumer choice,for the reason of rapid disintegration or dissolution, self administration even without water or chewing. Recent advances in technology have presented viable dosage alternatives for patients who have difficulty in swallowing tablets and capsules.
In view of above facts we are aiming to prepare orodispersible tablets containing mouth fresheners. Purpose of incorporating mouth fresheners in orodispersible tablets is used to achieve the local and as comparatively fast actions as well as increase the elegance of formulation in tablets forms.Presently available mouth fresheners are in the form of pills, flakes, mint etc. such formulations are may not be stability for herbal extracts due to suitable and volatile nature of the extracts.
Mouth dissolving tablets are mouth disintegrating tablets prepared using super disintegrators such as crosspovidone, croscarnalose sodium sodium starch glycolate etc. usually gas generating agents Sodium bicarbonate anhydrous citric acid are used in the development of formulation such tablets are intended to dissolve immediately in the mouth for ease absorption and mouth dispersibility.Recently Ayurvedic formulations containing carminatives and mouth freshening agents are employed as a churna or pellets which are needed advanced novel formulations like mouth dissolving tablets, coated pellets etc.
6.3 REVIEW OF LITERATURE
Ginger (Zingiber officinale, Z. officinale) has been used as a medicine since ancient time8. In Asian medical practices, dried ginger has been used to treat stomachache, diarrhea and nausea9-12. Recent studies have shown that Z. officinale has anti-inflammatory effects13and reduces pain and swelling associated with either rheumatoid or osteoarthritis14. It has also antioxidant, analgesic and anti pyretic properties15-17. Cardiovascular actions of Z. officinale such as decrease in blood pressure, heart rate18 and blood glucose19 is well known. The major pharmacological activity of Z. officinale appears to be due to gingerol and shogaol20. These two active compounds are reported to be responsible for the analgesic, anti-emetic, antipyretic and prostaglandin suppression of Z. officinale21. Ginger has a sialagogue action, stimulating the production of saliva, which makes swallowing easier. Sesquiterpene lactones are natural products responsible for the anti-inflammatory activity21.
Elettaria cardamomum Maton (Scitaminaceae) locally known as “elaichi” is a perennial herb,indigenous to India, Pakistan, Burma and Sri Lanka22. The cardamom is a popular food dditive and flavoring agent used by the people all over the world. Its medicinal properties have beendescribed in Ayurveda and Unani system of medicine. The various animal studies have shown its antioxidant23, antihepertensive24, gastroprotective24, anticancer25activities. 1-8 cineole a active component of seeds is demonstrated for its vasodialatory activites26.
Fennel fruit (Foeniculum vulgare Mill, Umbelliferae), is a widely used drug in traditional medicine. Fennel fruit is used to overcome a stomach ache, nausea, flatulence, vomiting, diarrhea, painful menstruation, and menstrual irregularity27. The seeds of fennel are used for chewing purpose in India and rest of the world. This plant is traditionally used and is being investigated for manytherapeutic activities28-32.
In view of the potential therapeutic utilities of the above plants for oral hygiene, an attempt will be made in the present study,to formulate and evaluate polyherbal oral dispersible tablets containing extracts of natural mouth fresheners such as ginger, cardamom and Fennel with the following objectives.
6.4 OBJECTIVES OF STUDY.
1. Ethanolic extraction of fennel, cardamom and ginger by cold extraction method.
2. Judicial selection of the extractions with additives of tablets to form orodispersible tablets which are intended for disintegration within 2 to 3 minutes and pH 7.4 Phosphate buffer.
3. Study of pre compression parameters and compressibility of orodispersible and placebo tablets.
4. Study of pre compression parameters and compressibility of orodispersible and placebo tablets containing herbal mouth fresheners.
5. Evaluation of flow properties, DT, Friability, Hardness, in-vitro dispersion of extraction loaded and placebo tablets.
6. Stability studies of selected formulations.
MATERIALS AND METHODS
Preparation of extracts by cold extraction method
Crude ethanol extracts of fennel, ginger and cardamom are prepared by soaking the required quantity of crude drug powder in ethanol for one week as per the standard methods. Cold extraction is preferred to avoid the loss of volatile aromatic compounds.
Preparation of Mixed Blend of Drug and Excipients
All the Ingredients were passed through mesh 60. Required quantity of each ingredient was taken for each specified formulation and all the ingredients were co grind in a mortar and pestle. The powder blend was evaluated for flow properties such as Bulk density, Tapped density, Compressibility index, Hausner ratio. Compression of Tablets (except magnesium stearate) was mixed homogenously and co grind in a mortar and pestle .Finally magnesium stearate wasadded and mixed for 5 min. The mixed blend of drug and excipients was compressed using cad mach single punch tablet punching machine to produce convex faced tablets weighing 150 mg each with a diameter of 8mm. a minimum of 50 tablets were prepared for each batch.
Physical characterization of fast dissolving tablets
The thickness was measured using vernier caliper. Weight variation was conducted as per specifications. Hardness test was performed using a Monsanto hardness tester. Friability was performed using a Roche friability testing apparatus.
7.1.EVALUATION PARAMETERS
Pre-compression Parameters
a) Flow properties
The tablet blends were evaluated for their bulk density, tapped density, carr’s index and flow properties. The tapping method was used to determine the tapped density, bulk density and percent carr’s index.
Post-compression Parameters
a) Tablet Hardness
The strength of tablet is expressed as tensile strength (Kg/cm2). The tablet crushing load, which is the force required to break a tablet into pieces by compression. It was measured using a tablet hardness tester (Monsanto hardness tester)33.
b) Weight Variation Test
Randomly selected 20 tablets were weighed individually and together in a single pan balance. The average weight was noted and standard deviation was calculated. IP limit for weight variation in case of tablets weighting up to 120 mg is ± 10%, 120 mg to 300 mg is ± 7.5% and more than 300 mg is ± 5%.
PD= (Wavg) – (W initial) / (W avg) x 100
Where PD= Percentage deviation, Wavg = Average weight of tablet,
Winitial = Individual weight of tablet.
c) Friability :
Roche friabilator was used for the purpose. This device subjects a number of tablets to the combined effect of abrasion and shock by utilizing a plastic chamber that revolves at 25 rpm dropping the tablets at a distance of 6 inches with each revolution. Pre-weighed 20 tablets were placed in the friabilator, which was then operated for 100 revolutions. Tablets were dusted and reweighed.
d) Disintegration Time
The disintegration time of tablet was measured in water (370C) according to USP Disintegration test apparatus. Three trials for each were performed34.
e)In vitro dispersion time :
In vitro dispersion time was measured by dropping a tablet in a beaker containing 50 ml of Sorenson's buffer pH 6.8. Three tablets from each formulation were randomly selected and in vitro dispersion time was performed35,36.
SOURCE OF DATA:
  • Indian Journal of Physiology and Pharmacology
  • Indian Journal of Pharmacology
  • Indian Journal of Pharmaceutical Sciences
  • Indian Journal of Science and Technology
  • Journal of General and Applied Microbiology
  • Applied Biochemistry and Microbiology
  • Planta Medica
  • Pubmed
  • J-Gate@Helinet(RGUHS)
HAS ETHICAL CLEARANCE BEEN OBTAINED FROM INSTITUTION IN CASE OF 7.0?
Not applicable

8.

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9

/

SIGNATURE OF THE CANDIDATE

10 / REMARKS OF THE GUIDE / The above mentioned information and literature has been extensively investigated, verified and was found to be correct. The present study will be carried out under my supervision and guidance.
11 / NAME AND DESIGNATION OF GUIDE

SIGNATURE

/ Shri.B.S.Patil,M. Pharm.,( PhD).,
Assistant Professor
Post Graduate Department of Pharmacognosy,
SET’s College of Pharmacy, S.R.Nagar,
Dharwad. Karnataka – 580002.
Mobile No.: +91-9449143440
E-mail:

12

/

NAME AND DESIGNATION OF CO – GUIDE

SIGNATURE / ------
13 / NAME AND DESIGNATION OF HOD
SIGNATURE / Dr. P. V. HABBU,M. Pharm., Ph.D.,
Professor & HOD
Post Graduate Department of Pharmacognosy,
SET’s College of Pharmacy, S.R.Nagar,
Dharwad. Karnataka – 580 002.
Mobile No.: +91 – 9448224894
E-mail:

14

/

REMARKS OF PRINCIPAL

/ The above mentioned information is correct and I recommend the same for approval.
15 / NAME OF THE PRINCIPAL
SIGNATURE / Dr. V. H. KULKARNI, M. Pharm., Ph.D.,
Principal, SET’s College of Pharmacy,
S.R.Nagar, Dharwad. Karnataka – 580002.
Mobile No.: +91 – 9448357804
E-mail:

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