Formulation Design, Development and Invitro Evaluation of Mouth Dissolving Tablets of Zolmitriptan

Manivannan, D (2018) Formulation Design, Development and Invitro Evaluation of Mouth Dissolving Tablets of Zolmitriptan. Masters thesis, J.K.K.Nattraja College of Pharmacy, Komarapalayam.


Download (4MB) | Preview


AIM &OBJECTIVES: Difficulty in swallowing (dysphagia) is a common problem of all age groups, especially the elderly and pediatrics, because of physiological changes associated with those groups. Other categories that experience problems in using conventional oral dosage forms include the mentally ill, uncooperative and patients suffering from nausea, motion sickness, sudden episodes of allergic attack or coughing. Sometimes it may be difficult to swallow conventional products due to non-availability of water. These problems led to the development of a novel type of solid oral dosage form called orodispersible tablet, which disintegrates/dissolves rapidly in saliva without the need of drinking water. The benefits in terms of patient compliance, rapid onset of action, increased bioavailability and good stability make these tablets popular as a dosage form of choice in the current market. Some drugs are in such cases bioavailability of drug is significantly greater than those observed from conventional tablet dosage form. The basic approach used in the development of the ODTs is the use of superdisintegrants. Many approaches have been developed to manufacture ODTs. These include vacuum drying direct compression, lyophilization and molding. The direct compression method is inexpensive and convenient for producing tablets of sufficient mechanical strength. Zolmitriptan are the new serotogenic agonist with excellent oral bioavailability exhibiting a potent symptomatic antimigraine effect. Zolmitriptan is a selectiveagonist of 5-HT1 B/D receptors. In the present study, orodispersible tablets of Zolmitriptan are designed by using polymers namely Pharmabusrst, Pearlitol Flash and Panexcea ODT. Effervescent substances like citric acid and sodium stearyl fumarate. Accelerated the superdisintegrant action and mask the bitter taste of zolmitriptan. The designed tablets were evaluated for thickness, hardness, friability, weight variation, in vitro dispersion time, wetting time, water absorption ratio, disintegration time, drug content uniformity, in vitro dissolution rate (in pH 6.8 phosphate buffer), short term stability and drug excipient interactions (IR spectroscopy). OBJECTIVES OF THE WORK: The present work is an attempt: 1. To formulate and evaluate orodispersible tablets. 2. To enhance the bioavailibity. 3. Ease of administration to paediatrics and geriatrics. 4. To evaluate for the pre-formulation characteristics of powder mixture like bulk density, flow property, angle of repose, compressibility index etc. 5. To evaluate the post-formulation characteristics of the tablet like hardness, friability, disintegration time, dispersion time, etc. 6. To carry out in vitro dissolution studies of the tablet formulations. 7. To carry out stability studies according to ICH guidelines To formulate orally disintegrating tablets of Zolmitriptan, 5 mg by a simple direct compression process and to evaluate the physico-chemical characteristics of the designed tablets against the marketed product. CONCLUSION: Orodispersible tablets of Zolmitriptan are prepared by direct compression method. The formulation FZ9 containing 10% of superdisintegrant (i.e) Pharmaburst ODT has shown best release with 100.3% at the end of 15minuts. The effervescent mixture further assists in taste masking of Zolmitriptan. According to FTIR studies there is no incompatibility shown in FZ9. The formulation FZ9 was stable at 40°C±2ºC and 75%RH±5%RH. In conclusion formulation FZ9 achieved the targets of the present study such as, • Not require water to swallow, but it should dissolve or disintegrate in the mouth in matter of seconds. • To mask the bitter taste. • Have a pleasant mouth feel. • Rapid dissolution of drug and absorption which may produce rapid, onset of action. • Improved bioavailability.

Item Type: Thesis (Masters)
Additional Information: Reg.No.261610254
Uncontrolled Keywords: Zolmitriptan ; Formulation Design ; Development ; Invitro Evaluation ; Mouth Dissolving Tablets.
Subjects: PHARMACY > Pharmaceutics
Depositing User: Subramani R
Date Deposited: 25 Jun 2019 01:58
Last Modified: 25 Jun 2019 02:01

Actions (login required)

View Item View Item