Effect of processing methods on xylitol-starch base co-processed adjuvant for orally disintegrating tablet...

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Orally disintegrating tablets (ODTs) offer a convenient, water-independent dosage form, improving patient compliance.
• Existing co-processed adjuvants lack a comprehensive profile of ideal characteristics like compressibility, rapid disintegration, and palatability for ODTs.

Purpose of the Study:

• To develop and characterize a xylitol-starch based co-processed adjuvant optimized for orally disintegrating tablet applications.
• To compare the efficacy of wet granulation and freeze-drying methods in producing the co-processed adjuvant.

Main Methods:

• Co-processed adjuvants were prepared using xylitol, starch, and crospovidone XL-10 via wet granulation and freeze-drying.
• Excipients were formulated into ODTs and evaluated for physical properties, disintegration time (in-vitro and in-situ), and structural analysis (FTIR, SEM, XRD).

Main Results:

• Formulation F6, utilizing freeze-drying, exhibited the fastest in-vitro (135.33±11.52 s) and in-situ (88.67±13.56s) disintegration times.
• Increased starch content correlated with decreased ODT disintegration time.
• Freeze-drying yielded smaller particle sizes and shorter disintegration times compared to wet granulation.

Conclusions:

• A novel xylitol-starch-crospovidone XL-10 co-processed excipient was successfully developed using freeze-drying.
• This co-processed excipient demonstrates suitability for ODT formulation due to its fast disintegration, good compressibility, and palatability.