Formulation and in-vitro characterization of fast-disintegrating herbal extract sublingual immunotherapy tablet for peanut-induced allergic asthma

治疗花生诱发过敏性哮喘的速崩中药提取物舌下免疫治疗片的配方及体外特性

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作者:K N Aswathy, Syed Mohammed Basheeruddin Asdaq, C K Saritha, Litha Thomas, Nithya Haridas, Vidya Viswanad, Ram Kumar Sahu, Santosh Fattepur, Abdulhakeem S Alamri, Walaa F Alsanie, Majid Alhomrani, Nagaraja Sreeharsha, Md Khalid Anwer

Background

Allergen immunotherapy (AIT) involves the regimen of gradually incrementing doses of the allergen, thereby inducing desensitization and tolerance. Sublingual Immunotherapy tablets (SLIT-tablets) have been formulated for several allergies and had manifested efficacy for allergic rhinitis and allergic asthma. SLIT promises an alternative method to other routes of AIT enabling patients to self-administer AIT.

Conclusion

The results indicated the suitability of formulated SLIT tablets for peanut induced allergic asthma.

Methods

The crude peanut extract was prepared by a simple extraction method and was subjected to quantitative and qualitative analysis. The extract was also characterised for its physical properties. The preformulation study for the extract and excipients of the tablet was performed using FT-IR spectroscopy and Differential scanning calorimetry. The tablet powder blends were characterised for pre-compression properties. The SLIT tablets were developed by direct compression and the post-compression evaluation was performed.

Objective

The study aimed to formulate fast disintegrating SLIT containing crude peanut extract for peanut-induced allergic asthma.

Results

The results of the quantitative and qualitative analysis of extract confirmed the presence of peanut proteins in the extract. The preformulation studies using FT-IR spectroscopy and Differential Scanning Calorimetry revealed that there is no significant interaction between the CPE and excipients. The pre-compression characterisation showed that the powder blends had good flowproperties. Three doses of SLIT tablets were formulated with each dose containing four batches and the tablet of each dose was optimized by studying the effect of varying concentrations of super disintegrants on disintegration time and dissolution rate. The post compression characterization of the tablets was performed and the optimized batch of the three doses with the concentration of 5% crospovidone and 2% croscarmellose sodium showed less wetting time and high-water absorption ratio, shorter disintegration time of 14secs and maximum drug release of >90% within 2-3 min.

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