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Published on: April 1, 2022
Mitigating breast cancer with intratumoral in situ pH-responsive abemaciclib-loaded novasome hydrogel
Maha M Ghalwash1, Randa Mohammed Zaki2,3, Obaid Afzal4
1Faculty of Pharmacy, Department of Pharmaceutics and Drug Manufacturing, Modern University for Technology and Information, Cairo, Egypt.
Abstract:
Abemaciclib (AMC) is a selective CDK4/6 inhibitor widely utilised for breast cancer therapy; however, its efficacy is compromised by poor bioavailability and low aqueous solubility. This study aimed to enhance the sustained release, targeting, and efficacy of AMC via developing an intratumoral, in situ pH-responsive AMC-loaded novasome (IPANF) hydrogel. The optimal AMC-novasome was tailored using Design-Expert® software and subsequently incorporated into a chitosan/glyceryl monooleate mixture to develop IPANF. The in vivo anti-tumour efficacy and safety profile of the IPANF were evaluated using an Ehrlich ascites carcinoma model. Within 24 h, the IPANF formulation exhibited a significantly sustained drug release by 65.31% compared to the free AMC suspension. The intratumoral IPANF resulted in a profound 96.08% reduction in tumour volume, a 70.46% recovery in body weight, and a suppression of the CA 15-3 and CA 27-29 levels by 92.66% and 91.23%, respectively. Notably, a 100% survival rate was observed in the intratumoral IPANF group. Histopathological assessments firmly validated the superior therapeutic efficacy of the intratumoral IPANF hydrogel. Furthermore, the intratumoral IPANF formulation demonstrated an excellent safety profile. These findings underscore the clinical potential of the intratumoral IPANF hydrogel as a highly efficient, localised, and safe platform for advanced breast cancer treatment.
Insights
This study developed a pH-responsive hydrogel loaded with abemaciclib (AMC) for localized breast cancer treatment. The novel formulation significantly reduced tumor volume and improved survival rates, offering a safer and more effective therapeutic option.
Area of Science:
- Biomedical Engineering
- Drug Delivery
- Oncology
Background:
- Abemaciclib (AMC) is an FDA-approved CDK4/6 inhibitor for breast cancer.
- Clinical use of AMC is limited by poor bioavailability and solubility.
- Novel drug delivery systems are needed to improve AMC's efficacy.
Purpose of the Study:
- To develop an intratumoral, pH-responsive hydrogel loaded with AMC-novasomes (IPANF).
- To enhance sustained release, localized targeting, and therapeutic efficacy of AMC.
- To evaluate the in vivo anti-tumor efficacy and safety of the IPANF hydrogel.
Main Methods:
- AMC-novasomes were optimized using Design-Expert® software.
- Novasomes were incorporated into a chitosan/glyceryl monooleate hydrogel for pH-responsive in situ gelling.
- In vivo studies were conducted using an Ehrlich ascites carcinoma tumor model.
Main Results:
- The optimized IPANF formulation showed sustained drug release, reducing cumulative release by 65.31% within 24 hours.
- Intratumoral IPANF administration led to a 96.08% reduction in tumor volume and suppressed biomarkers CA 15-3 and CA 27-29.
- A 100% survival rate was observed in the IPANF-treated group with increased intratumoral drug exposure and an excellent safety profile.
Conclusions:
- The intratumoral IPANF hydrogel demonstrates significant potential for localized and sustained delivery of AMC.
- This formulation offers enhanced anti-tumor efficacy and improved safety for advanced breast cancer treatment.
- IPANF represents a promising platform for localized cancer therapy.
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