S.N.I.O.P. PUSAD

1. SEMINAR ON
“Development and evaluation of medicated jelly of model
drug. ”
Major Advisor:
Dr. R. B. Wakade
Presented by:
Mr. Paras B. Pophalkar

2. CONTENTS
Introduction
Review of Literature
Need of study
Objectives
Plan of Work
Results

3. Introduction
 Oral drug delivery is the most favoured route for the administration of
various medications and jellies are the most accepted dosage form.
 The benefits of the present research work is increased retention time of the
dosage form in oral cavity and increased bioavailability, reduction in gastric
irritation by passing first pass metabolism.
 Formulation of oral medicated jelly is one kind of novel oral formulation
which can be easily taken by patients of advanced age and particularly
patients with dsphagia.

4. con….
 Paediatric formulations are available in different types of oral dosage forms
like syrup, suspension, dry syrup, etc. But so many problems are arising in the
usage of that type of formulation in paediatrics like, stability, dosage wastage,
dose dumping etc.
 For the drugs having significant buccal absorption, dosage forms such as
medicated jelly permit more rapid therapeutic action as compared to oral
dosage forms.
 Children in particular may consider jelly as a more preferred method of drug
administration compared with liquids and tablets.

5. Review of Literature

6. Have prepared and evaluated Clotrimazole jellies for the treatement of
candidiasis using xanthan gum with different concentrations. The sucrose based
jellies were prepared by heating and congealing method
(Javalgikar et al )
Have prepared and evaluate ketoconazole jellies using polymers such as
xanthan gum, sodium carboxy methyl cellulose with different concentrations.
(Rao et al)
It has conducted to formulate and evaluate the unit molded medicated jelly
containing Palonosetron hydrochloride with various gelling agent like tragacanth
gum, gelatin, xantham gum for treatment of induce nausea and vomiting.
(Dubey et al)

7. Need of study
 This kind of formulation is very good alternative for drug delivery to paediatrics,
geriatric and dysphagic patients.
 Oral jellies have significant advantages of both solid and liquid dosage forms, as they
remain solid during storage which aid in stability of dosage forms and transform in
liquid like form within few seconds to minute after its administration.
 Thus, oral jellies have tremendous scope for being the delivery system for most of
the drugs in future.
 The benefits of these prepared jellies are increased bioavailability by-passing first
pass metabolism, jellies were prepared by dispersing the gelling agent in water.

9. • Aim- Aim of this study is to develop medicated jelly of model drug for effective
delivery in paediatric patient.
• To achieve the formulation of efficient oral medicated jellies, following objectives
are charted out.
 To design stable and efficient oral medicated jellies.
 To study the effect of gelling agent on stability of prepared jelly.
 To study the effect of polymer to drug concentration on release pattern of drug.
 To study the effect of organoleptic additives on stability and behavior of drug
delivery system.
 To analyze the effect of polymer to polymer ratio on release pattern of drug .

11. • Present proposed research work has been planned as follow –
 Literature survey.
 Selection of drug and polymer & other excipients.
 Procurement of drug and polymer & other excipients.
 Drug polymer compatibility study.
 Preliminary study of drug and polymer.
 Formulation of oral jellies
 Evaluation of oral jellies
a. Physical Appearances
b. Determination of pH
c. Stickiness and grittiness
d. Syneresis
e. In- vitro drug release
f. Weight variation
g. Content Uniformity
h. Stability Study

12. Drug Profile
 Drug- Ondansetron HCL
 Structural formula:
Fig 1: Structure of Ondansetron HCL
 Molecular weight : 365.86 grams
 Appearance : White to off-white powder
 Solubility : Water and normal saline.

13. EXPERIMENTAL WORK
Preparation Method
1. All the ingredients will be weighed accurately.
2. In one beaker sugar syrup will be prepared by adding 33.4 gm of sugar in
beaker and make up the volume up to 50ml.
3. To that solution gelling agent will be add with constant stirring and heated to
dissolve to achieve desired stiffness.
4. When gelling agent will completely dissolve, stabilizer and citric acid will
be added and again stirred to enhance softness of the jelly and to maintain
pH respectively, and then boil for few minutes.

14. 5. After boiling the above solution, preservative will be added to that solution,
mixed thoroughly and uniformly.
6. Now drug is weight accurately, dissolved in suitable vehicle and added before
jelly is allowed to set, mix thoroughly.
7. Then whole solution was transferred in to moulds and then allowed it for cooling
and settling undisturbed by proper covering the moulds to avoid exposure to outer
environment.

15. Formulation of medicated jelly
Sr. No. Ingredients F1 F2 F3 F4 F5 F6
1. Drug(Ondansetron) 40 mg 40 mg 40 mg 40 mg 40 mg 40 mg
2. Gelatin 3.5 gm 4gm 4.5gm - - -
3. Carbapol 934 - - - 3.5gm 4gm 4.5gm
4. Dextrose 1 gm 1 gm 1 gm 1 gm 1 gm 1 gm
5. Citric acid 0.5gm 0.5gm 0.5gm 0.5gm 0.5gm 0.5gm
6. Methyl paraben 0.10gm 0.10gm 0.10gm 0.10gm 0.10gm 0.10gm
7. Sucrose 33.4gm 33.4gm 33.4gm 33.4gm 33.4gm 33.4gm
8. Colour Q. S. Q. S. Q. S. Q. S. Q. S. Q. S.
9. Flavour Q. S. Q. S. Q. S. Q. S. Q. S. Q. S.
10. Purified water 11.46m 10.96ml 10.46ml 11.46ml 10.96ml 10.46ml

16. Evaluation of medicated jelly
a. Physical Appearances
b. Determination of pH
c. Stickiness and grittiness
d. Syneresis
e. In- vitro drug release
f. Weight variation
g. Content Uniformity
h. Stability Study

17. RESULTS DISCUSSION
Physicochemical Characteristics of Ondansetron HCL
Test Observation
Colour White to off white amorphous powder
Odour
Odourless
Taste
Characteristics

18. Solubility of Ondansetron HCL
Sr. No. Solvent Solubility
1.Water Sparingly soluble
2.Buffer solution 6.8 Soluble
3.Methanol Soluble

19. Standard Curve of Ondansetron HCL:
Calibration curve of Ondansetron hcl in saline water

20. Determination of λmax:
The UV spectrum of Ondansetron HCL in saline water showed maximum
absorption at 250 nm .

21. FT-IR Of Ondansetron Hcl:

22. Evaluation of Ondansetron medicated jelly
Time Percent drug
release
F1 F2 F3 F4 F5 F6
0 0 0 0 0 0 0
5 19.5 23 51.75 24.25 9.25 33.12
10 40.75 44.25 69.25 41.5 12.5 43.75
15 56.5 64.25 90.5 55.75 56.5 45.75
20 81.5 95.75 102.25 62.25 45.25 66.75
25 110.5 141.5 108.75 70 56.5 69.75
30 122.75 163.75 113 81.25 65 72.75

23. Fig. In-vitro dissolution profile of F1– F3 formulation

24. Fig. In-vitro dissolution profile of F4– F5 formulation

25. In-vitro release studies of all the formulations were also
compared and evaluate. The results showed that the drug
release profile of formulation F3 was considered as
optimized formulation and used for further study.

26. Evaluation of optimized batch (F3)
Weight variation
Determination of pH
The pH of the prepared formulations was found in the range of 4.10 ± 0.03
which was acidic. Sucrose may precipitate in the presence of citric acid on
standing. Therefore, a minimum quantity of citric acid was added just to
maintain the pH.
The average weight of ten jellies was taken to determine weight variation.
The jellies were taken out of the moulds in a beaker and weighed
individually, pooled and mixed.
The weight variation was found between 4.95%±0.58% in all prepared jelly
formulations (F3)

27. Content uniformity
The drug content of F3 formulation was found to be in the range of
87.67 % which shows formulation have uniformity of content.
Syneresis
Syneresis was more pronounced in the formulations, where
separation of water from gelling agent was employed. It was
observed after 60 days of jelly preparation.
Stability studies
Formulation F3 showed best results. appearance, pH, viscosity,
sugar crystallization, stiffness, syneresis and drug content at the end
of 60 days.

28. Results of stability studies on optimized formulations after 30 days
Formulation Temperature
(°C)
pH Drug
content
(%w/w)
F3 25°C 4.10 86.40
Results of stability studies on optimized formulations after 60 days
Formulation Temperature
(°C)
pH Drug
content
(%w/w)
F3 25°C 4.05 84.05

29. Conclusion
 In the present study, the jellies loaded with ondansetron were successfully
formulated using gelatin, carbapol. The optimized formulations showed acceptable
physico-chemical properties and stability.
 Formulations F3, could be effectively employed for oral delivery for paediatric,
geriatric and dysphagic patients as alternatives to solid oral dosage forms.
 The study reveals that ondansetron oral jelly released the drug as rapid manner with
improved bioavailability.
 The observed results were found that the concentration of gelatin carbopol 934 can
influenced the release rate & other physico chemical properties.
 Thus it can be concluded that ondansetron jellies are beneficial in improving the
bioavailability of drug as compared to other oral fast releasing dosage forms.

30. Future Scope
 In-vivo in- vitro correlation
 Formulating various formulation using different gelling agent
and gums in combination.
 To overcome the Scumness of Jelly as minimum as possible.
 To evaluate antiemetic activity in human volunteers as well
as in experimental animal model.
 To formulate jelly for other categories of drugs.

31. References:
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Formulation, An International Journal Of Pharmaceutical Sciences, ISSN: 0978-7908,
Apr-Jun 2016, 13-20 .
 Beeram V,: Formulation, development and evaluation of cefixime oral medicated jelly.
Indian Journal of Pharmaceutical science. 2010; 78(2): 68-73.
 Hiroshi Ninomiya, Toshio Shimizu, Masatake Dairaku, Takeshi Komagata, Masayo
Misawa. Jellied medicinal composition for oral administration. Unites States Patent US
593.22-35.
 Cooper and Gun. Dispensing for Pharmaceutics, CBS Publishers & Distributors, Daraya
Ganj New Delhi, Twelfth Edition.2000,: 214-216.
 Seth AK. Pharmaceutics – II (Dispensing and Formulation). S Vikas & Co., Jalandhar
City; : 287 -290.

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