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Copy of Copy of pro

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Transcript of Copy of Copy of pro

Advantages
Thank You
Formulation and Evaluation of Diclofenac Sodium Fast Dissolving Films

Dr. Dalia Abdel Aty
T.A. Radwa EL Masry
Contents:
Aim of Study
Definition
A new drug delivery system for the oral delivery, It’s placed on the patient’s tongue, wet by saliva, It hydrates and adheres onto the site of application.
Fast dissolving films are the most advanced form of solid dosage forms due to more flexibility and comfort,
It improves the efficacy of Active pharmaceutical ingredients dissolving within minute,
Suitable for pediatrics &geriatrics.
Characters of oral thin films
Very thin, fast and accurate dosing in a safe format,
They are typically the size of a postage stamp.
Special features:
Thin elegant film,
Available in various shapes and sizes,
Non-obstructive,
Excellent mucoadhesive,
Quick dissolving and Rapid Release
Flow chart of development of oral dosage form
Fast Dissolving Films
Fast dissolving tablets
Modified Release Dosage Form
.
Conventional Tablet
.
Rapid onset of action,
It disintegrates in the saliva within few seconds,
Improved patient compliance in pediatrics and geriatrics,
Under any circumstances patient can take his medicine,
Films are used as alternative to conventional oral dosage form,
Reduced hepatic first pass effect,
Disadvantages
High doses can’t be incorporated,
Drugs with obvious odor and taste can’t be given,
Drugs unstable in buccal PH can’t be administered,
Eating and drinking maybe restricted.
Composition of oral thin films
Water soluble polymers,
Plasticizers,
Sweetening agents,
Saliva stimulating agents,
Flavoring agents,
Coloring agents,
Stabilizing and thickening agents.
Common Polymers:
Pullulan,
Hydroxypropyl methylcellulose,
Carboxy methylcellulose,
Polyvinyl alcohol or sodium alginate.
Placticiser:
Sweetening agents :
Saliva stimulating agents
Other Agents
Improves the flexibility of the film and reduces the brittleness of the film ,eg: Propylene glycol.
Used to improve the palatability of the formulations, eg :Sucrose, Dextrose .
Used to increase the rate of production of saliva & faster disintegration of strip formulation, eg: Citric acid and lactic acid
Flavoring agents
Coloring agents
Stabilizing and thickening agents:
Other Agents:
Used to mask the unpleasant taste,
e.g.: Oil vanilla, peppermint, chocolate and cinnamon.
e.g.: titanuim dioxide
It improves the viscosity and the consistency.
Manufacturing methods:
Hot-melt extrusion.
Solid dispersion extrusion.
Rolling.
Semi-solid casting.
Solvent casting
The current preferred manufacturing process we are going to use for making film is solvent casting.
Film
Homogeneous solution is spread on flat surface
Both solutions are mixed with rapid stirring
Drug and excipients dissolve in the same solution
Polymer dissolves in solvent to form solution
Solvent Casting Method
Release mechanism:
Packaging
:
Expensive packaging, specific processing, and special care are required during manufacturing and storage to protect the dosage of fast-dissolving dosage forms.
Packaging of oral thin films:
System can be packaged using various options such as: single pouch, blister card with multiple units, multiple-unit dispenser and continuous roll dispenser.
Commercial oral strips:
Oral soluble films are used to prevent nausea and vomiting that may be caused by surgery, by medicines used to treat cancer (chemotherapy) or by radiation therapy,
Contains one of several antihistamines and is used for the temporary relief of seasonal and perennial allergy symptoms,
This product is used to relieve symptoms of extra gas such as belching, bloating, and feelings of pressure/discomfort in the stomach. Simethicone helps break up gas bubbles in the gut,
Banadryl
Gas-X
Zuplenz
Sudafed
Quick-Dissolve Orally Disintegrating Strips are a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily,
Theraflu
Preventing or treating symptoms of hay fever, other allergies, and colds, such as runny nose, sneezing, itching of the nose and throat, coughing, and itchy, watery eyes.
Dr. Dalia Abdelaty , Dr. Radwa EL Masry
for help, support and care.
Special thanks to:
Preparation of different formulae of fast dissolving oral films by using different water soluble polymers,
Evaluation tests for fast dissolving films:
Evaluation parameters for fast dissolving film:
Appearance of films,
Uniformity of weight of the films,
Thickness uniformity of the films,
Folding endurance,
Surface pH,
Drug content,
In-vitro disintegration time.
The drug is released from the dosage form upon disintegration and dissolution,


The disintegration and dissolving times are prolonged as the film thickness increases,


The disintegration and dissolving times may be further influenced, by varying the formulation composition of the film.
Evaluation of these preparations to select the best oral thin film of diclofenac by quality control tests,
Aim of study,
Introduction,
Composition of oral thin film,
Manufacturing methods,
Experimental work,
Results & Discussion, Conclusion.
Presented by:
RS 502
Project Pharmaceutics
Supervised by:

Mariam Ihab (094697)
Yassmin Hussain
(073491)
Zeinab Saad
(082507)
No need for water or spoon,
Improved Bioavailability,
Site specific action and local action,
Destructive acidic environment of stomach can be avoided,
,

Polymers Properties
y
Results and Discussion:
Calibration curve was constructed in methanol as the solvent system,
Linear plot with R^2value (0.9947) and slope of 0.0463 was obtained when absobance value of the working standard solutions were plotted against concentration,
Calibration curve is represented in the following graph.
Folding endurance test:
Done by repeated folding of the strip at the same place till the strip breaks. The number of times the film is folded without breaking is computed as the folding endurance value.
Disintegration time test:
Done by recording the time the film takes to dissolve in phosphate buffer at PH=6.8 , until the film disappears.
Weight uniformity test:
The film is put over the balance and the result is recorded

in gm.
Weigh(0.1 gm, 0.2gm, 0.3gm) from (CMC and HPMC)
Oven
Dissolve in
drops of glycerin and 10 mls of purified warm water in the beaker
so they changed to be solutions
Leave in
Trials Done to choose the best formulae:
First Experiment:
At 120 degrees the concentrations of CMC were kept for 5 hours,
Observation:
the films were over dried.
Third Experiment:
The concentrations of HPMC polymer were kept at room temperature over night .
Observation:
they didn't dry.
The next day they were put in oven at 70 degrees for 1.5 hours
Observation:
they were over dried.
Forth experiment:
At 50 degrees for 3 hours the concentrations of HPMC were kept in oven then the temperature is lowered to 40 degrees & left over night,
Observation:
the concentrations dried and made films.
Evaluation tests
Second Experiment:
At 40 degrees the concentrations of CMC were kept in oven over night.
Observation:
they dried and made films.
Experimental Work:
Methodology:
Equipments:
Materials:
Carboxymethyl cellulose (CMC),
Hydroxypropylmethyl cellulose (HPMC E15),
Distilled Water,
Methanol,
Glycerin,
Phosphate buffer at PH 6.8,
Diclofenac Sodium.
Calibration Curve
Conclusion:
Beaker,
Petri dishes,
Heater,
Oven,
Glass rod,
Weight balance,
UV spectrophotometer,
PH meter.
S
U.V Spectrophotometer
Transfer to
Petri dish

The the composition of the six formulations of Diclofenac sodium fast dissolving film:

The FDF was dissolved in buffer solution at pH 7.4 and the drug content was measured at 246 nm.

Drug Content:
The FDF is put in a closed Petri plate in 0.1 ml of distilled water. The FDF is placed under digital pH meter to determine the surface PH.
In vitro- drug release:
In vitro- drug Release
Relationship between the % cumulative amounts released from Diclofenac Sodium fast film and time:
Relationship between the % cumulative amounts released from F1- F3 Diclofenac sodium fast dissolving film and time:
Relationship between the % cumulative amounts released from F4- F6 Diclofenac sodium fast dissolving film and time:
After evaluation of the six formulae of CMC and HPMC-E15 of OTF. 3% HPMC-E15 showed the best folding endurance , weight, dissolution, disintegration & PH properties. So the 3% HPMC-E15 was proved to be the best formulae of Diclofenac Sodium film.
Surface PH:


Evaluation of different Fast Dissolving Films
The films from each batch were taken and placed in a 500 ml of phosphate buffer at pH 6.8. 5ml of the drug releasing media was withdrawn at various time intervals of 1, 2, 3, 4 and 5 minutes and replaced by the same volume of the buffer .These samples were filtered through 0.45ug membrane filter. The filtrate was diluted suitably with buffer and the drug was estimated in each by UV at 288nm
In vitro- drug Release
Relationship between the % cumulative amounts released from Diclofenac Sodium fast film and time:
Relationship between the % cumulative amounts released from F4- F6 Diclofenac sodium fast dissolving film and time:
Good Shelf Life
Good wetting and spreadability properties
Show fast disintegration
Non-toxic Non-irritant
Not-expensive
Shouldn’t cause infections in the oral mucusa
Introduction
Evaluation tests:
Weight uniformity test:
The film is put over the balance and the result is recorded

in gm.
The FDF is put in a closed Petri plate in 0.1 ml of distilled water. The FDF is placed under digital pH meter to determine the surface PH.
Surface PH:

In vitro- drug release:
The films from each batch were taken and placed in a 500 ml of phosphate buffer at pH 6.8. 5ml of the drug releasing media was withdrawn at various time intervals of 1, 2, 3, 4 and 5 minutes and replaced by the same volume of the buffer .These samples were filtered through 0.45ug membrane filter. The filtrate was diluted suitably with buffer and the drug was estimated in each by UV at 288nm

The FDF was dissolved in buffer solution at pH 6.8 and the drug content was measured at 288 nm.

Drug Content:
Folding endurance test:
Done by repeated folding of the strip at the same place till the strip breaks. The number of times the film is folded without breaking is computed as the folding endurance value.
In vitro- drug Release
Relationship between the % cumulative amounts released from Diclofenac Sodium fast film and time:
Relationship between the % cumulative amounts released from F1- F3 Diclofenac sodium fast dissolving film and time:

Done by recording the time the film takes to dissolve in phosphate buffer at PH=6.8 , until the film disappears.
Disintegration time test:
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