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Risperidone/Randomly Methylated β-Cyclodextrin Inclusion Complex-Compatibility Study with Pharmaceutical Excipients.

Laura Sbârcea^1,2, Ionuț-Mihai Tănase³, Adriana Ledeți^1,2

¹Department Pharmacy I, Faculty of Pharmacy, "Victor Babeş" University of Medicine and Pharmacy, 2 Eftimie Murgu Square, 300041 Timisoara, Romania.

Molecules (Basel, Switzerland)

|April 3, 2021

Summary

Encapsulating risperidone (RSP) with randomly methylated β-cyclodextrin (RM-β-CD) enhances its solubility and stability. This supramolecular adduct is compatible with starch, magnesium stearate, and microcrystalline cellulose, aiding new drug formulation development.

Keywords:

compatibility studies excipients inclusion complex randomly methylated β-cyclodextrin risperidone solubility stability

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Area of Science:

Pharmaceutical Sciences
Drug Delivery
Supramolecular Chemistry

Background:

Risperidone (RSP) is an atypical antipsychotic with poor water solubility and high lipophilicity.
RSP exhibits incompatibilities with common pharmaceutical excipients like magnesium stearate and lactose.
Improving RSP's biopharmaceutical profile is crucial for effective drug formulation.

Purpose of the Study:

To enhance the solubility and stability of risperidone (RSP) through encapsulation.
To investigate the formation and characteristics of RSP-RM-β-CD inclusion complexes.
To assess the compatibility of the RSP-RM-β-CD adduct with key pharmaceutical excipients.

Main Methods:

Formation of inclusion complexes using randomly methylated β-cyclodextrin (RM-β-CD).
Characterization via thermal methods, PXRD, UATR-FTIR, UV spectroscopy, and solubility studies.
Compatibility assessment using thermoanalytical tools and spectroscopic techniques.

Main Results:

Successful formation of a 1:1 RSP-RM-β-CD inclusion complex with enhanced solubility.
The supramolecular adduct showed no interactions with starch, magnesium stearate, and cellulose microcrystalline.
Incompatibility was observed between the RSP-RM-β-CD adduct and anhydrous lactose.

Conclusions:

The RSP-RM-β-CD supramolecular adduct is a promising candidate for developing stable and bioavailable formulations.
The study identified suitable excipients (starch, magnesium stearate, cellulose microcrystalline) for solid dosage forms.
This research facilitates informed selection of excipients for improved risperidone drug products.