Innovative dosage form of medicinal product containing a dose amount of senna fruit extract (Sennae fructus extractum aquosum siccum)

Introduction: The extract Sennae fructus extractum aquosum siccum, which was produced by Finzelberg in compliance with the European Medicines Agency's specifications and contains structurally complex hydroxyanthracenes, was the source of inspiration for the creation of a novel dosage form that possesses a high pharmaceutical availability of biologically active phytoconstituents. Objective: The extract's granulometric form and compatible excipients made from microcrystalline cellulose presented a technological challenge for the creation and production of a morphologically stable and pharmacokinetically effective dosage form through direct compression. Materials and methods: The direct compression technology was employed to manufacture alternative model formulations of an ellipsoidal tablet that contained senna fruit extract (Sennae fructus extractum) and no more than 15 mg of hydroxyanthracenes per single dose. Morphological and pharmacokinetic parameters of the model dosage form were determined using pharmacopeial methods. Results: The calculated Pj.u. values in water and phosphate buffer at pH( a H + ) = 6.88, as well as the determined pharmaceutical availability Qt), facilitated the estimation of the influence of hydrogen-ion activity and ionic strength on the solubility of hydroxyanthracenes and their diffusion rate into the external compartment (Fe3+ complex). The tablet's morphological parameters underwent substantial modifications during the expansion of the crystallographic structure of microcrystalline cellulose, as indicated by time-dependent measurements. Conclusions: A direct compression process was employed to produce a dosage form containing Sennae fructus extractum aquosum siccum under industrial manufacturing conditions, which demonstrated a high level of pharmaceutical availability in model receptor media. The study's findings contribute to the understanding of how hydroxyanthracenes function in the lower gastrointestinal tract.