Design and optimization of a probiotic tablet for gastrointestinal tolerance by a simplex-centroid mixture

Area of Science:

• Pharmaceutical Sciences
• Biotechnology
• Materials Science

Background:

• Probiotic viability and gastrointestinal tolerance are crucial for therapeutic efficacy.
• Biopolymers are increasingly explored as excipients for drug delivery systems.
• Optimizing formulation is key to protecting probiotics during transit through the gastrointestinal tract.

Purpose of the Study:

• To evaluate the impact of hydroxypropyl methylcellulose and alginate on the gastrointestinal tolerance of probiotic tablets containing Saccharomyces boulardii.
• To determine an optimal excipient formulation using a simplex-centroid mixture design.
• To assess the microbial viability and dissolution characteristics of the formulated probiotic tablets.

Main Methods:

• A simplex-centroid mixture design was employed using design of experiment (DOE) software.
• Hydroxypropyl methylcellulose and alginate were investigated as biopolymer excipients.
• Microbial viability and dissolution time were key parameters for formulation evaluation.

Main Results:

• An optimal formulation comprised 39.01% carboxymethylcellulose and 60.99% alginate.
• This formulation demonstrated protection against stomach acidity and favorable dissolution times.
• Probiotic tablets exhibited enhanced stability at 4°C, maintaining viability above 10^6 CFU/tablet after six months at room temperature.

Conclusions:

• The simplex-centroid mixture design is a valid approach for formulating gastrointestinally tolerant probiotic tablets.
• The developed formulation shows potential for commercial production of stable and effective probiotic yeast tablets.
• This research contributes to the advancement of probiotic delivery systems with improved survival rates.