Characterisation and optimisation of diclofenac sodium orodispersible thin film formulation

Abstract

Oral Thin Film (OTF) is a newly emerging drug delivery system which has many benefits for patients. Although there has been some formulation of OTF products, these have mainly been as confectionary or dental health products. The most significant benefit of this dosage format will only be realised once more pharmaceutical products become available. Within this paper, OTF strips containing Diclofenac Sodium were prepared using the solvent casting method and then characterised to ensure the method could conform to acceptable levels of uniformity, the mean (SD) diclofenac sodium content was 25.43(1.39) mg, range 22.84-27.44 mg. Bioburden was tested against coliforms, yeasts and moulds and all results were confirmed to be <10 CFU/g, 2 also similar dissolution profile when compared to a commercial product to ensure biowaiver. An acceptable level of uniformity of mass was produced. K-F titration was employed to reduce the water content of the strips and it was found to be acceptable, this represented a level of water which would not be viable for microbial growth. The technique employed here in the production of OTF resulted in high quality products and amenability to being up scaled. Furthermore, the characterisation method was also sufficient to assess the quality of the products and may be used for future analysis of OTF pharmaceuticals.

Trends in the Characterization Methods of Orodispersible Films

“…The residual water content needs particular attention because a certain amount of water can be desired to ensure the flexibility of the ODF and to circumvent brittleness [24]; but at the same time, a high amount can alter the mechanical properties and promote stickiness and microbiological bioburden or instability of the loaded API [5,30]. Even though the residual water content depends on the characteristics of film-forming material and the highest values reported in the literature (i.e.…”

“…The probe tack test measures the force required to separate the test probe tip from ODF with predefined dimension. The test can be performed using texture analyzer testing machine which measure the maximum detachment stress calculated by dividing the maximum detachment force by the probe surface area [30].…”

Optimal Design, Characterization and Preliminary Safety Evaluation of an Edible Orodispersible Formulation for Pediatric Tuberculosis Pharmacotherapy

“…A single blinded approach was used to evaluate taste acceptability and physical appearance of optimized drug loaded orodispersible formulation (each containing 25 mg PZA) by human volunteers (n = 5) [68,69]. Each volunteer was requested to allow formulations disperse in their mouths and to record the taste of each formulation on the provided chart after some seconds (under a minute) before removing formulation remnants from their mouths without ingestion.…”

“…The bitterness and quality attributes were evaluated using a 4-point hedonic scale with 1 point = very bitter, 2 points = moderate to bitter, 3 points = slightly bitter and 4 points = tasteless/taste masked). An average numerical value indicating the overall acceptability of the formulation was computed [68,69].…”

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

“…Dissolution testing is carried out for FDFs according to compendial methods. [123] A phosphate buffer is utilised with pH of 6.8 [123] or 5.7 (to simulate saliva). [102] The solution temperature is maintained at 37 ± 1C, however, the compendial apparatus usually is not suitable for measuring the dissolution rate of drug from FDFs.…”