(T1130-07-41) Novel 3D Printed Polypill for Diabetes Mellitus Management and Associated Cardiovascular Risks

Purpose: The purpose of this study was to develop a novel Polypill using Direct powder extrusion Technology that Combines Extended-Release Metformin Hydrochloride, Immediate release Atorvastatin Calcium. The aim was to enhance the solubility of Atorvastatin Calcium and provide extended release of freely soluble Metformin Hydrochloride by using Thermoplastic Polymers using Bio X 3D Printer. The combination of these drugs within a single dosage form intends to streamline therapy for patients, ensuring better management of their condition and reducing the risk of Diabetes associated cardiovascular complications. Metformin Hydrochloride has a plasma half-life of 6.2 hours and its exhibits high solubility in water and Atorvastatin Ca is Slightly soluble in water and has Plasma half-life of 14hrs.

Methods: The impact of various parameters on the drug release profile was thoroughly investigated, including polymer concentration, temperature, pressure, printing speed, and layer height of the Bio X 3D printer. These factors were meticulously optimized to ensure precise control over the drug release kinetics. The printed tablets were further evaluated for differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FTIR) to assess their physical and chemical properties. Additionally, assay tests were conducted to verify the accuracy and consistency of drug content within the tablets.

Results: Novel 3D-printed polypill was successfully developed using atorvastatin Calcium and Metformin hydrochloride through direct powder extrusion technology. The transformation of atorvastatin calcium from a crystalline to an amorphous state was achieved, significantly enhancing its solubility. For metformin hydrochloride, Eudragit RSPO was utilized as a polymer to effectively control the drug release. The assay results confirmed the precision of the 3D printing process, with atorvastatin tablets exhibiting a drug content of 99.72% and metformin hydrochloride tablets showing a content of 102.4%. These findings demonstrate the reliability of the 3D printing technique in producing dosage forms with consistent and accurate drug content.

Conclusion: The development of a novel 3D-printed polypill using direct powder extrusion technology effectively combines atorvastatin and metformin hydrochloride to enhance medication adherence and therapeutic efficacy. Atorvastatin Calcium transformation to an amorphous state was achieved, while the use of Eudragit RSPO controlled the metformin Hydrochloride release. The precise drug content, with assays of 99.72% for atorvastatin and 102.4% for metformin, highlights the reliability of the 3D printing process. This innovative approach simplifies treatment regimens for patients with diabetes and cardiovascular risks, improving drug bioavailability and patient outcomes

Formulation composition and Printing Parameters

Bio-X 3D Printed Tablets

DSC Thermogram of Atorvastatin Calcium Printed Tablets