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Stabilization and target delivery of Nattokinase using compression coating.

D Law¹, Z Zhang

¹Centre for Formulation Engineering, Department of Chemical Engineering, School of Engineering, University of Birmingham, Edgbaston, Birmingham, UK.

Drug Development and Industrial Pharmacy

|May 24, 2007

Summary

This study developed a new Nattokinase (NKCP) powder formulation for enhanced stability and controlled gastrointestinal release. Coated tablets successfully protected the enzyme in gastric conditions, ensuring targeted intestinal delivery.

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Area of Science:

Pharmaceutical Technology
Biochemistry
Enzyme Stabilization

Background:

Nattokinase (NKCP) is a nutraceutical enzyme with therapeutic potential.
Stabilizing NKCP in powder form and controlling its release in the gastrointestinal tract are critical for efficacy.
Existing formulations may not offer adequate protection or targeted delivery.

Purpose of the Study:

To develop a novel powder formulation for Nattokinase (NKCP).
To stabilize NKCP and control its release rate within the human gastrointestinal tract.
To evaluate the protective effect and release characteristics of the new formulation.

Main Methods:

NKCP powders were compacted into tablets using direct compression.
Tablets were coated with a mixture of Eudragit L100-55 (enteric material) and Hydroxypropylcellulose (HPC).
Enzyme activity was assessed via amidolytic assay; release rates were quantified using bicinchoninic acid assay in simulated gastric and intestinal fluids.

Main Results:

NKCP activity was found to be independent of compaction pressure.
The enteric coating effectively protected NKCP from denaturation in artificial gastric juice.
In vitro experiments demonstrated controlled release of NKCP into simulated intestinal fluid.

Conclusions:

The developed coated tablet formulation successfully stabilizes Nattokinase (NKCP) in powder form.
The formulation provides protection against gastric conditions and enables controlled release to the intestine.
This approach holds promise for enhancing the bioavailability and therapeutic application of nutraceutical enzymes.