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Solubility Enhancement of Raloxifene Using Inclusion Complexes and Cogrinding Method.

Payal H Patil¹, Veena S Belgamwar¹, Pratibha R Patil¹

¹Department of Pharmaceutics, R. C. Patel Institute of Pharmaceutical Education and Research, Near Karvand Naka, Shirpur, Dhule, Maharashtra 425405, India.

Journal of Pharmaceutics

|November 12, 2015

Summary

This study improved the solubility and dissolution of raloxifene hydrochloride (RLX) using hydroxypropyl-β-cyclodextrin (HPβCD) complexation and modified guar gum (MGG) cogrinding. HPβCD complexation showed superior enhancement for this poorly water-soluble drug.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Materials Science

Background:

Raloxifene HCl (RLX) is a practically water-insoluble drug.
Enhancing solubility and dissolution is crucial for improving RLX bioavailability.
Novel drug delivery strategies are needed for poorly soluble compounds.

Purpose of the Study:

To enhance the solubility and dissolution rate of raloxifene HCl (RLX).
To compare two distinct methods for improving RLX solubility: HPβCD complexation and MGG cogrinding.
To characterize the prepared formulations and evaluate their efficacy.

Main Methods:

Kneading of RLX with hydroxypropyl-β-cyclodextrin (HPβCD).
Cogrinding of RLX with modified guar gum (MGG).
Characterization using DSC, XRD, SEM, and FTIR; solubility and dissolution studies were performed.

Main Results:

Both HPβCD complexation and MGG cogrinding significantly increased RLX solubility and dissolution rate.
Characterization confirmed the formation of drug-excipient complexes/mixtures.
HPβCD complexation demonstrated a more significant enhancement in drug solubility compared to MGG cogrinding.

Conclusions:

HPβCD complexation is a highly effective method for enhancing the solubility and dissolution of poorly water-soluble drugs like RLX.
MGG cogrinding offers a cost-effective and solvent-free alternative, utilizing a natural polymer as a surfactant.
The choice of method depends on the desired level of solubility enhancement and process considerations.