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Response Surface Method-driven Design of Experiments for The Sublingual Immunotherapy Tablets of Indonesian House Dust Mites Allergenic Extract Pratama, Yusuf Alif; Marhaeny, Honey Dzikri; Prasetya, I Made Slamet Putra; Pramesthi, Anak Agung Istri Evinia; Winarto, Sulistyanengci; Miatmoko, Andang; Ardianto, Chrismawan; Rahmadi, Mahardian; Taher, Muhammad; Khotib, Junaidi
JURNAL FARMASI DAN ILMU KEFARMASIAN INDONESIA Vol. 13 No. 1 (2026): JURNAL FARMASI DAN ILMU KEFARMASIAN INDONESIA
Publisher : Universitas Airlangga

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.20473/jfiki.v13i12026.1-11

Abstract

Background: Allergic diseases represent a significant global health burden, and current pharmacological treatments primarily offer symptomatic relief without addressing the underlying immune dysregulation. Allergen-specific immunotherapy (AIT) is the only disease-modifying approach capable of inducing long-term remission by targeting the immunological mechanisms that drive the allergic response. Sublingual immunotherapy (SLIT) is a noninvasive alternative to subcutaneous immunotherapy, leveraging the rich vascularisation and antigen-presenting cell population of the oral mucosa. Objective: SLIT tablets were formulated using Indonesian house dust mite (IHDM) allergenic extracts, with the aim of optimising tablet properties by modulating the disintegrant concentration and croscarmellose-to-crospovidone ratios. Methods: Six formulations, each with three batches, were prepared via direct compression, varying the total disintegrant content (5.25 and 10.5% w/w) and excipient ratios. The tablets were evaluated for hardness, disintegration time, friability, and dissolution, and specific allergenic protein release (Der p 1 as a marker) was quantified using ELISA. A 2 × 3 factorial experimental design was used in the DoE approach, with data analysed using GraphPad Prism and Minitab, and response surface methodology (RSM) applied via Stat-Ease 360. Results: Higher disintegrant concentrations reduced tablet hardness but increased friability and disintegration rates. Pareto analysis revealed that both the total disintegrant content and disintegrant ratio significantly influenced tablet performance. All formulations demonstrated favourable dissolution profiles. The optimised formulation (F2), containing 5.25% (w/w) total disintegrants with a croscarmellose-to-crospovidone ratio of 1.5:2, achieved a disintegration time of 4.33 ± 0.88 s, hardness of 89.20 ± 6.12 N, and friability of 0.00 ± 0.01 %. Conclusion: These findings support the potential of IHDM-based SLIT tablets as an effective and mechanistically rational platform for allergen immunotherapy, contributing not only to symptoms but also to long-term modification of allergic diseases
Co-Authors Abdul Rahem, Abdul Alma Nuril Aliyah Amiruddin Ana Yuda Anak Agung Sagung Dyah Pramesti Andarsari, Mareta R. Aniek S. Budiatin Anita Purnamayanti Aprilia, Pingkan Aqsha, Aulia Charis Arie Sulistyarini Arina Dery Puspitasari Bambang Sidharta Budi Suprapti Budiatin, Aniek S. Budiatin, Aniek Setiya Budiatin, Aniek Setiya Budiatin, Aniek Setya Budiatin, Aniek Setya Cahyo Wibisono Chris Alderman Chrismawan Ardianto Chrismawan Ardianto Dewi Melani Hariyadi Dewi W. Shinta Dewi Wara Shinta Didik Hasmono Eddy Rahardjo Farida Ifadotunnikmah Fathia Ramadiani Galuh Laksatrisna Pide Gesnita Nugraheni Gusti Noorrizka Veronika Ahmad Hapsari, Pharmasinta P. Hermansyah, Andi Heru Purwanto I Nengah Budi Sumartha I NYOMAN WIJAYA Ika Ayu Mentari Imam Susilo Indira D. Kharismawati Irvina Harini Junaidi Khotib Liempepas, Angelika Lina, Rifda Naufa Luke Wongso Mareta R. Andarsari Mareta Rindang Andarsari Marhaeny, Honey Dzikri Megawati, Selvi Miatmoko, Andang Muhammad Agus Syamsur Rijal Muhammad Taher Muhammad Zaki Bin Ramli Naufalina, Rifda Nia Widyasari Noorma Rosita Pharmasinta P. Hapsari Pingkan Aprilia Pramesthi, Anak Agung Istri Evinia Prasetya, I Made Slamet Putra Pratama, Yusuf Alif Priyandani, Yuni Rahman, Fakhrinnisa Wildani Ramadiani, Fathia Rifda Naufa Lina Rifda Naufalina Sairiyah, Siti Nasikatus Samirah Samirah Sarah Puspita Atmaja Shinta, Dewi W. Sjamsiah, Siti Sjamsiah, Siti Suharjono Suharjono, Suharjono Sukorini, Anila Impian Sumarno Sumarno . Sumarno Sumarno Sumartha, I Nengah Budi Taher, Muhammad Tarisya Dinda Saraya Toetik Aryani Tuhfatul Ulya Umi Athiyah, Umi Winarto, Sulistyanengci Winda Fatma Sari Wirasasmita, Yuyun Yulistiani Yulistiani Yulistiani, . Yusuf Alif Pratama Zainul Amiruddin Zakaria Zamrotul Izzah Zulkarnain, Bambang Subakti