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

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

doi:10.1016/j.sjbs.2021.12.031

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

Saudi J Biol Sci. 2022 Mar;29(3):1283-1297. doi: 10.1016/j.sjbs.2021.12.031. Epub 2021 Dec 22.

Authors

K N Aswathy¹, Syed Mohammed Basheeruddin Asdaq², C K Saritha¹, Litha Thomas³, Nithya Haridas⁴, Vidya Viswanad¹, Ram Kumar Sahu⁵, Santosh Fattepur⁶, Abdulhakeem S Alamri^{7

8}, Walaa F Alsanie^{7

8}, Majid Alhomrani^{7

8}, Nagaraja Sreeharsha^{9

10}, Md Khalid Anwer¹¹

Affiliations

¹ Department of Pharmaceutics, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham, AIMS Health Sciences Campus, Kochi 682041, Kerala, India.
² Department of Pharmacy Practice, College of Pharmacy, AlMaarefa University, Dariyah 13713, Riyadh, Saudi Arabia.
³ Department of Pharmaceutics, Krupanidhi College of Pharmacy, Bangalore 560035, Karnataka, India.
⁴ Department of Respiratory Medicine, AIMS Health Science Campus, Amrita Vishwa Vidyapeetham, Kochi, 682041, Kerala, India.
⁵ Department of Pharmaceutical Science, Assam University (A Central University), Silchar 788011, India.
⁶ School of Pharmacy, Management and Science University, Seksyen 13, 40100 Shah Alam, Selangor, Malaysia.
⁷ Department of Clinical Laboratory Sciences, The Faculty of Applied Medical Sciences, Taif University, Taif, Saudi Arabia.
⁸ Centre of Biomedical Sciences Research (CBSR), Deanship of Scientific Research, Taif University, Saudi Arabia.
⁹ Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Saudi Arabia.
¹⁰ Department of Pharmaceutics, Vidya Siri College of Pharmacy, Off Sarjapura Road, Bangalore 560035, India.
¹¹ Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Alkharj 11942, Saudi Arabia.

Abstract

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.

Objective: The study aimed to formulate fast disintegrating SLIT containing crude peanut extract 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.

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.

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

Keywords: Crude peanut extract; Disintegration time; Dissolution; Kinetic study; Sublingual immunotherapy; Super disintegrants.