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Development of Oral Tablet Formulation Containing Erlotinib: Randomly Methylated-β-cyclodextrin Inclusion Complex

Nazlı Erdoğar¹

¹Hacettepe University Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Turkey

Turkish Journal of Pharmaceutical Sciences

|November 1, 2021

Summary

This study developed an oral tablet formulation of erlotinib (ERL) using randomly methylated-β-cyclodextrin (RAMEB-CD) inclusion complexes. The novel formulation significantly enhanced ERL solubility and dissolution, offering a promising alternative for non-small cell lung cancer treatment.

Keywords:

Erlotinib direct compression dissolution inclusion complex

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Medicinal Chemistry

Background:

Erlotinib (ERL) is a tyrosine kinase inhibitor used for metastatic non-small cell lung cancer (NSCLC).
ERL exhibits low aqueous solubility, limiting its oral absorption and bioavailability.
Complexation strategies can overcome these pharmacokinetic limitations.

Purpose of the Study:

To develop and characterize an oral tablet formulation of ERL using randomly methylated-β-cyclodextrin (RAMEB-CD) inclusion complexes.
To enhance the solubility and oral bioavailability of ERL for NSCLC treatment.

Main Methods:

Erlotinib: RAMEB-CD inclusion complexes were prepared via co-lyophilization.
Structural characterization utilized X-ray diffractometry and Fourier-transform infrared spectroscopy.
Tablets were formulated using direct compression, and their physical properties (hardness, disintegration, dissolution) were evaluated.

Main Results:

Co-lyophilization successfully formed stable ERL: RAMEB-CD inclusion complexes.
Direct compression yielded tablets with acceptable physical characteristics and low moisture content.
Dissolution studies demonstrated a significant increase in ERL solubility, with 99% drug release within 60 minutes.

Conclusions:

The developed ERL: RAMEB-CD inclusion complex tablet formulation is a viable approach.
This formulation enhances ERL dissolution and holds potential for improved oral bioavailability.
It represents a promising alternative therapeutic strategy for NSCLC management.