CHAPTER-4 RATIONALE & PLAN OF WORK

4.1 Rationale

Ondansetron hydrochloride, a 5 HT3 antagonist is a powerful antiemetic drug which has oral
bioavailability of 60% due to hepatic first pass metabolism and has a short half-life of 5 h. To
overcome the above drawback, the present study is proposed to formulate and evaluate oral thin
films of ondansetron hydrochloride for efficient sublingual administration.
The objective of the work was to design oral thin films of a drug meant for management of
emesis. Ondansetron hydrochloride, a 5 HT3 antagonist is a powerful antiemetic drug.
Fast disintegrating oral thin films are solid dosage forms, which disperse or dissolve within one
minute, when placed in the mouth without drinking or chewing. Oral thin films [OTF] is gaining
interest rapidly in the pharmaceutical industry due to their many advantages the most important
being improved patient compliance especially in pediatric and geriatric population because of
their ease of administration. Today, OTFs are a proven and accepted technology for the systemic
delivery of APIs for over the counter medications and are in the early to mid development stages
for prescription drugs. Literature survey indicates that till now these films were used for delivery
of drugs meant for acute diseases.
Therefore, the objective of the present work is design to formulate and evaluate oral thin films of
ondansetron hydrochloride for efficient sublingual administration. Ondansetron, a
5HT3 antagonist is a potent antiemetic drug, which is used in control of nausea, vomiting
associated with cancer chemotherapy. It exhibits only 60–70% of oral bioavailability because of
first pass metabolism and has a relative short half-life of 3–5 h. Studies have shown that
ondansetron hydrochloride is well absorbed through the buccal or sublingual mucosa.

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 39

CHAPTER-4 RATIONALE & PLAN OF WORK

4.2 PLAN OF WORK

In the present studies it was proposed to design fast disintegrating oral thin films for
Ondansetron hydrochloride. The plan of work can be outlined as follows:
1. Literature survey
2. Selection of drug and excipients
3. Preformulation study
 Organoleptic characteristics; colour, odour, appearance
 Solubility
 Loss on drying
 Identification of drug by
a) Infrared spectroscopy
b) Ultra-violet spectroscopy
c) Melting point
 Partition coefficient
4. Quantitative estimation of Drug
5. Compatibility study
a] Differential Scanning Calorimetry
b] Infrared spectroscopy
c] Physical observation
6. Formulation of dosage form
7. Evaluation of dosage form
8. Stability study
9. Compilation of work

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 40