A new approach to drug delivery, to be considered an an alternative to current techniques of delivery

1. FORMULATION, EVALUATION
AND OPTIMIZATION OF
AZITHROMYCIN ORALLY
DISSOLVING FILM
Prepared by GARGI DAS
M.PHARM (PHARMACEUTICS)
Roll No. – 19320314003
Registration No. - 141932310009
Under the supervision of Mr. KH. HUSSAN REZA
(Assistant Professor)
Bengal School of Technology

2. FLOW OF CONTENTS
Introduction
Objective and purpose
Literature reviews
Proposed plan of work
Probable materials to be used for formulation
Drug profile
Formulation process
Work done so far
References

3. INTRODUCTION
Oral dissolving film is solid dosage form which
is thin polymeric strip incorporating and delivering
pharmaceutical active ingredients & once placed in
the mouth dissolves in a short period of time without
drinking water or chewing.
These are also called as:-
 Oral thin films
 Mouth dissolving films/strips.
 Buccal films/strips.
 Fast dissolving films.
 Oral strips.

4. Benefits of ODF:
 Quick onset of action and enhance efficacy.
 Avoidance / reduction of first pass metabolism.
 Improve patient compliance. Pain free
administration.
 No need of water.
 Films can be produced easily by industrially feasible
and scalable methods.

5. Limitation Of ODF:
 Drugs which are unstable at buccal pH cannot be
administered.
 Drugs which irritate the mucosa cannot be
administered by this route.
 Drug with small dose requirement can only be
administered.
 Special packaging method needed.

6. OBJECTIVE AND PURPOSES
The present study is an attempt to develop an
alternative dosage form for the existing conventional system
as Oral Dissolving Film (ODF) of Azithromycin for treating
infants (1-2 years).
In the present work an attempt is made to formulate
a ODF of Azithromycin that can immediately dissolve in the
oral cavity (30 second approximate) releasing the drug that
can reach to the systemic circulation via oral blood vessels,
resulting in a rapid onset of action by passing or reducing first
pass metabolism.
The Azithromycin ODF is planned to be prepared by
using various polymer grades within a planned statistical
framework of Design of Experiment that will help in product
development and optimization. Therefore, present work is
aimed to formulate and evaluate ODF by combining different
polymer grades to study the effectiveness in drug release
pattern.

7. LITERATURE REVIEW
 Dixit et al8, 2009 reviewed on Oral Strip Technology: Overview and future
potential. The review described about materials used in OST, critical manufacturing
aspects, applications, commercial technologies and future business prospects of this
technology.
 Patil et al1, 2012 reviewed on Fast Dissolving Oral Films: An Innovative Drug
Delivery System. The review described about the excipients required for formulation
along with methodologies and evaluation parameters.
 Ghodake et al9, 2013 reviewed on Mouth Dissolving Films: Innovative Vehicle for
Oral Drug Delivery. This review provided an account of various formulation methods
and their evaluation used in film formulation and applications of mouth dissolving film.
The conclusion was that the oral route is most popular route for the administration of
therapeutic agents as mouth dissolving film.
 Harber et al10, 2014 worked on Orally Administrable Films and Preparation
thereof. The invention related to an orally administrable mucoadhesive film which
comprises one or more bioactive ingredients and as a major film forming polymer at
least one alginate which is capable of forming a low viscosity aqueous solution. Also
provided a process for preparing such films.

8. PROPOSED PLAN OF WORK
 Preparation of calibration curve of azithromycin
dihydrate.
 Preformulation Study –
1. Identification tests of drug.
2. Drug excipients interaction studies.
 Formulation design –
 Formulation of ODF based on factorial design.
 Evaluation tests .

9. PROBABLE MATERIALS TO BE USED FOR
FORMULATION
Table 1: - List of materials to be used for formulation.
Name Rationality Source
Azithromycin Dihydrate Active Pharmaceutical
Ingredient
Standard Pharmaceutical Ltd.
Hydroxy Propyl Methyl
Cellulose E15 and E15
Premium LV,,E3 Premium LV,
E5 Premium LV, E6 Premium
LV.
Polymers, Film forming agent Loba Chemie.
Poly Vinyl Alcohol Polymer, Film forming Agent. sd fine chem ltd.
Poly Ethylene Glycol 400 Plasticizer Merck Specialities Private Ltd.
Glycerol Plasticizer Fisher Scientific
Menthol Flavoring agent B.S. Trading
Eucalyptol Flavoring agent B.S. Trading
Aspartame Sweetener B.S. Trading
Acesulfame Potassium Sweetener sd fine chem. ltd.
Citric Acid Salivary stimulating agent sd fine chem. ltd.

10. DRUG PROFILE
Drug: - Azithromycin Dihydrate.
Physicochemical Properties :-
 Molecular weight: - 785.02g/mol.
 Molecular formula: - C38H72N2O12. 2H 2O.
 Log P :- 4.02
 pKa :- 8.74 (at 25°C)
 Melting point :- 114°C
 Solubility: - Soluble in ethanol and methanol.

11. DRUG PROFILE
Pharmacokinetic Properties: -
 Biological half life: - 11-14 hours.
 Protein binding: - Serum protein binding is variable in
the concentration range approximately human exposure,
decreasing from 51% at 0.02 µg/ml to 7% at 2µg/ml.
Pharmacological and Clinical Activity :-
Azithromycin, a semi synthetic antibiotic belonging
to the macrolide subgroup of azalides, is used to treat
community acquired pneumonia, pelvic inflammatory
disease, pediatrics otitis media and pharyngitis, and
Mycobacterium avium complex (MAC) in patients with
HIV disease.

12. DRUG PROFILE

13. FORMULATION PROCESS
 Solvent casting.
 Rolling.
 Hot melt extrusion.
 Semisolid casting.
 FIG. 1 : -Solvent casting
apparatus

14. FIG. 2 : - The manufacturing techniques for
oral thin films, 1- Polymer mixing, 2- Layering
and mother roll formation, 3- Slitting of mother
roll, 4&5- packaging.

15. Work done so far….
Table 2: - Identification Tests (I.P)
Tests Procedure Result
Appearance of solution:- 0.5g of drug (azithromycin
dihydrate) was dissolved in
anhydrous ethanol & diluted to
50.0ml with the same solvent. The
solution should be clear and
colorless.
Solution was clear and colorless.
pH:- A solution was prepared by
dissolving 0.1g of drug in 25.0ml of
methanol and further diluting to
50.0ml with carbon dioxide free
water. The pH should be 9.00-
11.00.
9.83.
Infrared Spectroscopy:- As per method. The peaks were
matched with reference peaks of
drug.
Complied

16. FIG. 3:- IR Spectrum of Azithromycin dihydrate (Standard
drug).
FIG. 4: - IR Spectrum of Azithromycin dihydrate.

17. REFERENCES
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