Development and evaluation of therapeutically useful oral solid tablets containing natural extracts: a quality by design approach

Ujashkumar A Shah, Jayvadan K Patel, Tejas Vyas, Govindarajan Raghavan

Zydus Wellness Institute, Zydus Wellness Research & Development, Ahmedabad, Gujarat, India

Refer this article

Ujashkumar A. Shah, Jayvadan K Patel, Tejas Vyas, Govindarajan Raghavan, 2024. Development and evaluation of therapeutically useful oral solid tablets containing natural extracts: a quality by design approach. Journal of medical pharmaceutical and allied sciences, V 13 - I 2, Pages - 6449 – 6458. Doi: https://doi.org/10.55522/jmpas.V13I2.6023.

ABSTRACT

The quality target product profile was created for therapeutically useful oral solid tablets containing natural extracts. Important quality criteria were recognised. The risk priority no. was used to evaluate critical materials for initial risk assessment. Using Central Composite Design, the effects of critical parameters (croscarmellose sodium & PVP K-30) were investigated. The impact of the formulation variables X1: Croscarmellose sodium and X2: PVP K-30 on responses Y1: DT (Disintegration time in minutes) and Y2: Friability (%) were assessed. Factor X2: PVP K-30 was found to have a substantial impact on both the responses. The optimized formulation having Croscarmellose sodium-20mg/tab and PVP K-30 8 mg/tab meets the QTPP (quality target product profile) and essential requirements for oral solid tablets standards. Present research shows that QbD (quality by design) is an excellent method which comprehending the critical parameters for optimising therapeutically useful oral solid tablets containing natural extracts.

Keywords:

QbD -Quality by Design, Oral solid tablets, Natural extracts, QTPP -Quality target product profile, DOE- Design of Experiments, CQA- Critical quality attributes.

Full Text Article