Orodispersible Films: A Systematic Patent Review.
BACKGROUND
Nowadays, Oral Film Technology (OFT) has gained much attention among all the oral drug delivery systems. Fast dissolving film, fast disintegrating film, and orodispersible film are some synonymous words for this dosage form. Without a need of liquid for administration, this dosage form dissolves in the mouth. Typically, fast dissolving film dissolves from 1 to 30 seconds.


OBJECTIVE
At the root of its originality, many researchers patented their work on the aspect of orodispersible films using different drugs, polymers, excipients and employing various methods of preparation. The review focuses on details related to orodispersible films and their patents from 1979-2017, collected from various sources like USPTO, Google patent, Espacenet, Intellectual Property India.


RESULTS
For the ease of discussion, collected patents are segregated on the basis of drugs, polymers, and method of preparation. It was found that many researchers are shifting towards fast dissolving films for better patient compliance, extended efficacy, high bioavailability, fast dissolution, and disintegration. With the help of polymers blend suitable for the drug release and improved method of preparation various parameters like tensile strength, thickness, and pH etc. can be controlled.


CONCLUSION
It was observed that judicial selection of polymers and polymers blends and methods of preparation are key parameters in the formulation of orodispersible film.
Designing Fast-Dissolving Orodispersible Films of Amphotericin B for Oropharyngeal Candidiasis
Amphotericin B possesses high activity against Candida spp. with low risk of resistance. However, Amphotericin B’s high molecular weight compared to other antifungal drugs, such as miconazole and clotrimazole, and poor water solubility hampers its efficacy at the physiological conditions of the oropharyngeal cavity (saliva pH, limited volume for dissolution) and thereby limits its clinical use in oropharyngeal candidiasis. We have prepared fast-dissolving orodispersible films with high loading (1% w/w) using solvent casting that enables amphotericin B to remain solubilised in saliva in equilibrium between the monomeric and dimeric states, and able to produce a local antifungal effect. Optimisation of the amphotericin B-loaded orodispersible films was achieved by quality by design studies combining dextran and/or maltodextrin as dextrose-derived-polymer film formers with cellulose-derived film formers (hydroxypropylmethyl/hydroxypropyl cellulose in a 1:4 weight ratio), sorbitol for taste masking, microcrystalline cellulose (Avicel 200) or microcrystalline cellulose-carboxymethylcellulose sodium (Avicel CL-611) for enhancing the mechanical strength of the film, and polyethylene glycol 400 and glycerol (1:1 w/w) as plasticizers. The optimised amphotericin B orodispersible films (containing 1% AmB, 25% dextran, 25% maltodextrin, 5% sorbitol, 10% Avicel 200, 10% polyethylene glycol 400, 10% glycerol, 3% hydroxypropylmethyl cellulose acetate succinate, 12% hydroxypropyl cellulose) possessed a fast disintegration time (60 ± 3 s), quick release in artificial saliva (>80% in 10 min), high burst strength (2190 mN mm) and high efficacy against several Candida spp. (C. albicans, C. parapsilosis and C. krusei) (>15 mm inhibition halo). Amphotericin B orodispersible films are stable for two weeks at room temperature (25 °C) and up to 1 year in the fridge. Although further toxicological and in vivo efficacy studies are required, this novel Amphotericin B orodispersible films is a promising, physicochemically stable formulation with potential wide application in clinical practice, especially for immunocompromised patients suffering from oropharyngeal candidiasis.
Experimental investigation of the geotechnical properties and microstructure of lime-stabilized saline soils under freeze-thaw cycling
Abstract The Song-Nen Plain in northeastern China holds one of the three largest expanses of soda saline-alkali soil in the world. Due to its disadvantageous geotechnical properties, the saline soil in this area is unable to meet the needs of construction projects. This study evaluates the stabilizing effect of adding lime to such soils. Specifically, it investigates how the physicochemical and mechanical properties and microstructure of soda saline-alkali soil are altered by lime and how these changes are affected by both freeze-thaw cycling and the duration of curing. The results reveal that adding lime to saline soil transforms clay particles into sand and silt particles and causes the pore size distribution (PSD) to become bimodal, with small-pore and macropore populations. An increase in lime content leads to an increase in the unconfined compressive strength (UCS) but a gradual decrease in both the cation exchange capacity (CEC) and plastic index. Freeze-thaw cycles break up coarse particles and aggregate finer particles, increasing the diameter of macropores and decreasing the USC; however, the effect on specimens with >9% lime is negligible. It is further shown that the geotechnical properties of the soil change immediately after the addition of lime, indicating that the cation exchange reaction takes place very quickly. Furthermore, the pozzolanic reaction leads to an increase in the percentage of sand-sized particles and a decrease in porosity after 28 days of curing. Overall, these results indicate that it is feasible to use lime to improve the engineering properties of soda saline-alkali soil in this area.