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Purpose <p>Tuberculosis (TB) is a major contributor to the global antimicrobial resistance problems. As drug resistant TB incidences increase worldwide (particularly the multi-drug-resistant TB/Rifampicin-Resistant TB (MDR/RR-TB)), the challenge of finding more efficient management strategies to replace existing cumbersome treatment modalities (e.g., injections) persist. The World Health Organization’s (WHO’s) preferred recommendations for MDR/RR-TB treatment are all-oral drug regimens, a noteworthy pharmacotherapy advancement. Therefore, this study reports on the development of a novel multipolymeric chewable oral ring formulation of delamanid, an important drug component of the WHO’s recently endorsed MDR/RR-TB all-oral regimen for adults and children of all ages. Chewable oral formulations are attractive alternative drug delivery systems mainly due to their several advantages (e.g., appealing visual appearance, minimization of choking risks, water-free administration, convenience).</p> Method <p>The delamanid chewable oral ring was fabricated as a physicochemically intact, dissolvable, microporous matrix that can be easily masticated or sucked on by children (≥ 2 years) and adults. The lead delamanid chewable oral ring formulation was developed using a standard L25 Taguchi orthogonal array design incorporating six factors at five levels. The formulation process consisted of three stages—multipolymeric blending, sol gel transitioning, and lyophilization—which together yielded a stable, dissolvable, and microporous delamanid oral ring. The final drug product demonstrated a physicochemically robust structure that can be comfortably chewed or sucked by both children (≥2 years) and adults.</p> Results <p>The delamanid chewable oral ring was manageable, visually appealing, moderately sized (17.42 × 17.42 × 5.69 mm), light weight (0.42 g) and displayed average drug content of 96.79%. It was relatively fluffy (springiness = 0.70%) and micromechanically durable (hardness = 11.44 N, resilience = 0.90% and cohesiveness = 0.59%) but without the tendency to stick to chewing surfaces characterized by minimal adhesiveness (0.01 mJ). </p> Conclusion <p>The delamanid chewable oral ring may facilitate discreet, accurate dosing and can be taken without water, suggesting it could serve as a practical option for managing MDR/RR-TB in individuals aged 2 years and older.</p>

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Multipolymeric Oral Ring Formulation of Delamanid: Manufacture, Computer Aided Lead Selection and In vitro Proof of Concept Studies

  • 期刊论文

  • 发表日期：

    2026年3月14日

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  • Saba Abedin,
  • Parnian Noshadravan Angali,
  • Oluwatoyin A. Adeleke

摘要

Purpose

Tuberculosis (TB) is a major contributor to the global antimicrobial resistance problems. As drug resistant TB incidences increase worldwide (particularly the multi-drug-resistant TB/Rifampicin-Resistant TB (MDR/RR-TB)), the challenge of finding more efficient management strategies to replace existing cumbersome treatment modalities (e.g., injections) persist. The World Health Organization’s (WHO’s) preferred recommendations for MDR/RR-TB treatment are all-oral drug regimens, a noteworthy pharmacotherapy advancement. Therefore, this study reports on the development of a novel multipolymeric chewable oral ring formulation of delamanid, an important drug component of the WHO’s recently endorsed MDR/RR-TB all-oral regimen for adults and children of all ages. Chewable oral formulations are attractive alternative drug delivery systems mainly due to their several advantages (e.g., appealing visual appearance, minimization of choking risks, water-free administration, convenience).

Method

The delamanid chewable oral ring was fabricated as a physicochemically intact, dissolvable, microporous matrix that can be easily masticated or sucked on by children (≥ 2 years) and adults. The lead delamanid chewable oral ring formulation was developed using a standard L25 Taguchi orthogonal array design incorporating six factors at five levels. The formulation process consisted of three stages—multipolymeric blending, sol gel transitioning, and lyophilization—which together yielded a stable, dissolvable, and microporous delamanid oral ring. The final drug product demonstrated a physicochemically robust structure that can be comfortably chewed or sucked by both children (≥2 years) and adults.

Results

The delamanid chewable oral ring was manageable, visually appealing, moderately sized (17.42 × 17.42 × 5.69 mm), light weight (0.42 g) and displayed average drug content of 96.79%. It was relatively fluffy (springiness = 0.70%) and micromechanically durable (hardness = 11.44 N, resilience = 0.90% and cohesiveness = 0.59%) but without the tendency to stick to chewing surfaces characterized by minimal adhesiveness (0.01 mJ).

Conclusion

The delamanid chewable oral ring may facilitate discreet, accurate dosing and can be taken without water, suggesting it could serve as a practical option for managing MDR/RR-TB in individuals aged 2 years and older.