ABSTRACT

Among other skin allergies, hay fever (allergic rhinitis) and urticaria (hives) are symptoms of allergies that can be treated with loratadine, a second-generation non-sedating antihistamine. In an effort to create a dosage form for fast action that is helpful in controlling severe allergy symptoms, aids in enhancing bioavailability, and is highly easy for administration—without the need for water—a quick release film formulation of loratadine was attempted. The artificial sweetener aspartame, which also works as a saliva stimulant, was used in an effort to cover up the drug's salty flavour. Polymers like hydroxyl propyl methylcellulose (HPMC K4M), polyvinyl pyrrolidone-K30 (PVP-K30), and poly vinyl alcohol were used to make loratadine films via solvent casting (PVA). They passed all of the physical and chemical tests that were performed on them, including those for tensile strength, weight uniformity, thickness, foldingendurance, drug content uniformity, surface pH, swelling index, and percentage elongation. The IR research found no evidence of a drug-polymer interaction. The formulations were also examined for their release characteristics in vitro using a USP dissolving equipment and in vivo blood histamine levels in animals. Fast-dissolving films of loratadine made using the polymers HPMC K4M, PVP-K30, and PVA showed a notable increase in dissolution rate when compared to commercial tablets. The stability analyses showed that when the formulations were maintained at refrigerator temperatures of 2–8 °C and room temperatures of 25–30 °C, the drug concentration did not noticeably alter. Further in vivo study was carried out to determine blood histamine level in animal and compared its rapid action with marketed product. The formulations were also subjected for in vivo blood histamine level estimation in animals. The in vivo blood histamine level estimation in animals exhibited rapid pharmacological response to justify the fast release of the drug from formulations than marketed product. Keywords: Fast dissolving films, Loratadine, Sublingual films, Solvent casting, Animals
Publication date: 01/04/2024

https://ijbpas.com/pdf/2024/April/MS_IJBPAS_2024_7929.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.4.7929