Evaluation of Buccal Drug Delivery system.pptx

Prepared By: Pavan Gowda
Topic: Evaluation of Buccal Drug Delivery system
RR College of Pharmacy

1. 16-05-2022 © R R INSTITUTIONS , BANGALORE 1 MODERN DRUG DELIVERY SYSTEM EVALUATION OF BUCCAL DRUG DELIVERY SYSTEM RR COLLEGE OF PHARMACY SUBMITTED BY Pavan Kumar 1 st sem M. Pharm Dept. of Pharmaceutics SUBMITTED TO Dr. Geetha Lakshmi HOD Dept of Pharmaceutics

2. Evaluation of BDDS Dosage forms → Tablets Patches Semi-solids Sprays In-vitro test ↓ Weight variation yes yes Assay yes yes yes yes Thickness yes yes Friability yes Disintegration time yes yes Residence time yes yes yes Tensile strength yes Folding endurance yes Viscosity yes Droplet size yes Dissolution yes yes yes Mucoadhesion Strength yes yes yes Pemeability test yes yes yes yes 16-05-2022 © R R INSTITUTIONS , BANGALORE 2

3. Some important evaluation tests 1.IN VITRO DISSOLUTION STUDIES : Dissolution studies are carried out for all the formulations, employing USP dissolution apparatus at 37°C, rotated at constant speed of 50 rpm using 900 ml of dissolution medium. The layer membrane of buccal tablet attached to the glass disk with instant adhesive (cyanoacrylate adhesive). The disk was allocated to the bottom of the dissolution vessel. An aliquot of the sample is withdrawn at suitable time interval and the volume is replaced with fresh dissolution medium. The sample is analyzed spectrophotometrically at specified nm 16-05-2022 © R R INSTITUTIONS , BANGALORE 3

4. 2. IN VITRO RESIDENCE TIME In-Vivo residence time is determined using IP disintegration apparatus using 900 ml of the disintegration medium maintaining at 37°C. The rat intestinal mucosa segments, each of 3 cm length, are to be glued to the surface of a glass slab, which is then vertically fixed to the apparatus. Three Mucoadhesive films of each prepared formulation are hydrated on one surface and the hydrated surface is brought into contact with the mucosal membrane. The glass slab is vertically fixed to immerse in the buffer solution at the lowest point, and is out at the highest point. The time required for complete detachment of the films from the mucosal surface is to be recorded 16-05-2022 © R R INSTITUTIONS , BANGALORE 4

5. 3.MUCOADHESION STRENGTH Modified balance method : Fresh Porcine buccal mucosa obtained from a local slaughterhouse was stored in pH 6.6 phosphate buffer at 4 degrees Celsius upon collection. The experiment was performed within 3 hours of procurement of the mucosa. The porcine buccal mucosa was fixed to the stainless steel piece with cyanoacrylate adhesive and placed in a beaker, then pH 6.6 phosphate buffer was added into the beaker up to the upper surface of the porcine buccal mucosa to maintain buccal mucosal viability during the experiment. Then the tablet was attached to the upper clamp of the apparatus and the beaker was raised slowly to establish contact between porcine buccal mucosa and the tablet. A preload of 50 gm was placed on the clamp for 5 mins to establish adhesive bond between the tablet and porcine buccal mucosa. 16-05-2022 © R R INSTITUTIONS , BANGALORE 5

6. 16-05-2022 © R R INSTITUTIONS , BANGALORE 6 After completion of preload time, preload was removed from the clamp and water was added into the beaker from burette at a constant rate. The weight of water required to detach the tablet from porcine buccal mucosa was noted as mucoadhesive strength and experiment was repeated with fresh mucosa in an identical manner.

7. 4.Ex vivo permeation study In this study, porcine buccal mucosa was used as a membrane. Diffusion studies were carried out, to evaluate the permeability of drug across the porcine buccal mucosal membrane, by using glass surface Franz diffusion cell. Porcine buccal mucosa was obtained from local slaughter house and used within 2 hrs of slaughter. The tissue was stored in phosphate buffer pH 7.4 solution upon collection. Whole assembly was placed in water bath maintained at 37±10ºC. Buccal epithelium was allowed to stabilization for period of 1hr and hydrodynamic in receiver chamber was maintained by stirring with magnetic bead at 50 rpm. After the stabilization of buccal epithelium, the patch was kept on buccal epithelium and 3ml of phosphate buffer of 6.8pH was added in donor chamber. The sample of 1 ml were withdrawn at the time interval of 1 hour upto 8hrs and replaced with equal volume of fresh dissolution medium. The sink condition was maintained throughout the study. The withdrawn sample was diluted to 5ml. The amount of drug was determined by UV-VIS Spectrophotometer. 16-05-2022 © R R INSTITUTIONS , BANGALORE 7

8. EVALUATION OF BUCCAL TABLETS Thickness : The thickness of buccal tablets was determined using digital micrometer. Ten individual tablets from each batch were used and the results averaged Weight variation : Weight variation was performed for 20 tablets from each batch using an electronic balance and average values were calculated . Hardness : Hardness was conducted for 3 tablets from each batch using Monsanto hardness tester and average values were calculated. 16-05-2022 © R R INSTITUTIONS , BANGALORE 8

9. Assay : Ten tablets were weighed and grounded in a mortar and pestle to get fine powder. powder equivalent to the mass of one tablet was dissolved in methanol by sonication for 30 min and filtered through filter paper. The drug content was analysed spectrophotometrically at 274nm using an UV spectrophotometer. Disintegration test : Test is performed for buccal tablets which are not having backing membrane. six tablets were taken randomly from each batch and placed in USP disintegration apparatus (baskets type). Apparatus was run for 4 hr and the basket was lift from the fluid, observe whether all of the tablets have disintegrate 16-05-2022 © R R INSTITUTIONS , BANGALORE 9

10. EVALUATION OF BUCCAL PATCHES/FILMS Film Weight and Thickness : The weight of each prepared film was measured using a digital balance among the three films of every formulation and the average weight was calculated. Similarly the thickness of each film was measured using a micrometer screw gauge at different points of the film and the average was calculated Folding Endurance : • Folding endurance of the films was premeditated by repeatedly folding one film at the same place till it broke or folded up to 300 times manually. • The number of times the film could be folded at the same place until it breaks gives you value of folding endurance. 16-05-2022 © R R INSTITUTIONS , BANGALORE 10

11. Tensile Strength It is defined as the resistance of the material to a force tending to tear it separately and is identified as the maximum stress in the stress–strain curve. It was determined using an Instron universal testing instrument with a 5-kg load cell. Films were held between two clamps positioned at a distance of 3 cm and were pulled by the top clamp at a rate of 100 mm/m, the force and elongation were measured when the film broke. It was calculated by the replicate of 3 times. It is given by the following equation, Tensile strength = Force at break (N) / Cross - sectional area of the film (m𝑚2 ). Elongation Break The elongation at break is a measurement of the maximum deformation the film can undergo before tearing apart. It is calculated using the following equation. Elongation at break = Increase in length of break / Initial film length x 100 33 16-05-2022 © R R INSTITUTIONS , BANGALORE 11

12. EVALUATION OF BUCCAL SEMI SOLID DOSAGE FORMS Viscosity studies The rheological studies were carried out using Brookfield programmable DVIII + model pro II type (USA). The viscosity of in situ gels were determined at different angular. Calculate the viscosity. Evaluation was conducted in triplicate. Spreadability • For the determination of spreadabilty, excess of sample was applied in between two glass slides and was compressed to uniform thickness by placing 1000g weight for 5min. Weight (50g) was added to the upper glass slide. The time in which the upper glass slide moves over to the lower plate was taken as measure of spreadability (S) . • S=ML/T 42 Where, M= weight tide to upper slide L = length moved on the glass slide T=time taken 16-05-2022 © R R INSTITUTIONS , BANGALORE 12

13. Swelling Index The films were weighed individually and placed on the surface of an agar plate kept in an incubator maintained at 37±0.2°c and the samples were allowed to swell. An increase in the weight of the film was noted in regular intervals of time and the weight was calculated. The percent swelling, %S was calculated using the following equation: Percent Swelling (%S) = (X t - X o /X o ) x 100 Where, X t = the weight of the swollen film after time t X o = the initial film weight at zero time. 16-05-2022 © R R INSTITUTIONS , BANGALORE 13

14. Reference N.K.Jain , Controlled and Novel drug delivery, CBS publishers &distributors International journal of pharmaceutical sciences and research vol.4,issue 3. www.google.com https://www.slideshare.net 16-05-2022 © R R INSTITUTIONS , BANGALORE 14

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