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Flexipill: A novel 3D printed flexible dose combination for hypertension with a floating element
Yasir Karkar1, Tanzeela Anis2, Amal Ali Elkordy1
1School of Pharmacy and Pharmaceutical Sciences, University of Sunderland, Sunderland SR1 3SD, United Kingdom.
Insights
This study introduces the Flexipill, a 3D-printed antihypertensive medication combining personalized dosing with improved patient adherence. It addresses polypharmacy challenges by offering flexible drug combinations for hypertension management.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- 3D Printing in Medicine
Background:
- Hypertension affects one in three adults globally, often requiring multiple medications (polypharmacy), especially in geriatric patients.
- Polypharmacy can decrease patient adherence, leading to suboptimal treatment outcomes.
- Fixed-dose combinations (polypills) improve adherence but lack treatment personalization and dose titration flexibility.
Purpose of the Study:
- To develop a 3D-printed flexible dose combination (Flexipill) for personalized antihypertensive therapy.
- To balance regulatory requirements with the need for tailored drug combinations at the point of care.
- To create an antihypertensive Flexipill with distinct drug release profiles for individual components.
Main Methods:
- Utilizing 3D printing technology to create a novel antihypertensive Flexipill.
- Formulating individual drug units with specific release characteristics and stability considerations.
- Developing a propranolol HCl unit as a floating dosage form for enhanced bioavailability.
- Optimizing enalapril maleate formulation to prevent thermal degradation during printing.
- Designing a hydrochlorothiazide unit for immediate drug release.
Main Results:
- Successfully printed an antihypertensive Flexipill with tailored drug release profiles.
- The propranolol HCl unit demonstrated flotation for 9 hours, releasing over 90% of the drug.
- Enalapril maleate was printed at 150°C, below its degradation temperature, ensuring stability.
- The hydrochlorothiazide unit achieved immediate release of over 90% within the first hour.
Conclusions:
- The Flexipill offers a flexible and personalized approach to antihypertensive combination therapy.
- 3D printing enables the creation of customized drug delivery systems addressing polypharmacy and adherence issues.
- This technology provides a viable solution for personalized medicine, bridging the gap between research and clinical application.
Abstract:
Hypertension is highly prevalent worldwide, affecting approximately one in three adults. The pathophysiology of hypertension is multifactorial, which led recent guidelines to recommend the initiation of treatment with more than one antihypertensive agent. This exacerbates the existing issue of polypharmacy, particularly among geriatric patients. Polypharmacy can lead to a reduction in patient adherence to the treatment. As a result, many clinical studies have investigated using fixed-dose combinations to address this issue. These studies have demonstrated the effectiveness of a polypill in improving patient adherence. However, a polypill limits the flexibility for dose titration and personalisation of treatment. Therefore, when 3D printing was first introduced to pharmaceutical formulation, researchers recognised the potential of this technology for drug personalisation and the creation of more flexible drug combinations. Nonetheless, regulatory concerns still limit the translation of these research efforts into clinical applications that can benefit the patient. Consequently, this study seeks to bridge the existing gap by identifying a balanced approach between regulatory requirements and the concept of personalised drug combinations. The Flexipill is a flexible dose combination that does not require printing at the pharmacy level. It can be printed at a quality-controlled facility and assembled according to patient needs at the point of care. In this work, an antihypertensive Flexipill was printed, with each unit having different drug release profiles and formulation requirements. The propranolol HCl unit was printed as a floating unit to improve its solubility and bioavailability. It floated for 9 h, releasing over 90 % of the drug content. The enalapril maleate unit was formulated to avoid thermal degradation by printing at 150 °C, which is lower than its degradation temperature. Moreover, hydrochlorothiazide was formulated to provide immediate release of over 90 % of the drug within the first hour.
