Development of Monteverdia ilicifolia Spray-Dried Extract for a Clinical Trial: A Successful Scale-Up Experience with a Brazilian Native Plant

Background/Objectives: Our group has been trying to bring scientific rationale to the quality, safety and efficacy of Brazilian medicinal plants. This work was the first step of a broader project evaluating the potential of Monteverdia ilicifolia capsules for managing dyspepsia in a randomized, double-blind clinical trial. M. ilicifolia is a native species widely used in Brazilian traditional medicine for treating gastric disturbances. The central aim of the present work was to develop capsules containing an M. ilicifolia standardized spray-dried extract (SDP) on a lab scale and to transfer the process to a Brazilian pharmaceutical industry for a scale-up approach, achieving high-quality capsule production for our clinical trial Methods: Quality control of raw materials and derivative products followed the official plant monograph, specifically total tannin content (Folin-Dennis method) and epicatechin content (HPLC analysis). The leaves of M. ilicifolia were used to prepare an infusion for 15 minutes. The infusion was filtered and concentrated, and cornstarch and colloidal silicon dioxide were added to produce a M. illicifolia spray-dried powder, which was subsequently encapsulated. Results: The raw material and SDP had high total tannins and epicatechin content. The number of capsules required to achieve 860 mg of SDP was three capsules size 0. Due to the blind tests, the dose of 400 mg and the omeprazole (20 mg) were also encapsulated in three capsules size 0. The capsules prepared on a semi-industrial scale showed an immediate release profile. The outcomes from this study evidenced that the developed technology produced suitable spray-dried powder to be employed as hard gelatin capsules for clinical trials. Conclusions: Although a traditional aqueous extract was the starting point of the work, the technological development of SDP was successfully achieved and transferred to the Brazilian pharmaceutical industry. Following Good Manufacturing Practices, this approach can provide efficient (and quickly) high-quality SDP and corresponding capsules for clinical evidence-based phytotherapy.