Design and development of preservative free herbal dosage forms

Abstract

quotIn this study a representative of mono-herbal (Ashoka) as well as poly-herbal (NP-044) actives were chosen, so that the technology developed could serve as a platform and the same can be extrapolated to commercial scale to plethora of similar products. newlineIn case of solid dosage forms, the results of all the parameters analyzed showed that the pasteurization/auraclaving did not affect the micrometric properties of the granules like compressibility index and Hausner ratio, leading to a formulation with an excellent pharmaceutical characteristics, such as, disintegration time, hardness, and friability outcomes newlineas compared to similar formulation with preservatives (without pasteurization). newlineThe tablets and capsules of mono-herbal (Ashoka) and poly-herbal actives (NP-044) formulated by incorporating pasteurization technique not only achieved bioburden control, but also comply with other vital pharmaceutical parameters like stability and quality parameters as per pharmacopeial standards. Given that, the developed process with pasteurization does not involve use of any chemicals or irradiation, the approach becomes more relevant toward the development of preservative-free herbal solid dosage forms and thus can be employed without any regulatory concerns for product registrations. newlineWith reference to preservative-free liquid oral formulation, controlled input material, combination of low water activity with co-solvent system along with self-preserving techniques were successfully yielded a liquid oral product with shelf life stability. This research work addresses the solution, not just to overcome the inherent risk of using preservatives in herbal dosage forms but also open up a new avenue of promoting a concept to herbal formulation as completely safe and preservative-free . Further, the outcome suggests that, the daunting task of manufacturing preservative-free herbal formulations could easily and consistently achieved by a methodical and scientific approach.