Abstract
This work aimed to develop a three-dimensional printed (3DP) tablet containing glimepiride (GLMP) and/or rosuvastatin (RSV) for treatment of dyslipidemia in patients with diabetes. Curcumin oil was extracted from the dried rhizomes of Curcuma longa and utilized to develop a self-nanoemulsifying drug delivery system (SNEDDS). Screening mixture experimental design was conducted to develop SNEDDS formulation with a minimum droplet size. Five different semi-solid pastes were prepared and rheologically characterized. The prepared pastes were used to develop 3DP tablets using extrusion printing. The quality attributes of the 3DP tablets were evaluated. A non-compartmental extravascular pharmacokinetic model was implemented to investigate the in vivo behavior of the prepared tablets and the studied marketed products. The optimized SNEDDS, of a 94.43 ± 3.55 nm droplet size, was found to contain 15%, 75%, and 10% of oil, polyethylene glycol 400, and tween 80, respectively. The prepared pastes revealed a shear-thinning of pseudoplastic flow behavior. Flat-faced round tablets of 15 mm diameter and 5.6–11.2 mm thickness were successfully printed and illustrated good criteria for friability, weight variation, and content uniformity. Drug release was superior from SNEDDS-based tablets when compared to non-SNEDDS tablets. Scanning electron microscopy study of the 3DP tablets revealed a semi-porous surface that exhibited some curvature with the appearance of tortuosity and a gel porous-like structure of the inner section. GLMP and RSV demonstrated relative bioavailability of 159.50% and 245.16%, respectively. Accordingly, the developed 3DP tablets could be considered as a promising combined oral drug therapy used in treatment of metabolic disorders. However, clinical studies are needed to investigate their efficacy and safety.
Highlights
The ability to tune or tailor a formulation by flexible control of drug formulation, dose and physicochemical properties has a great impact on the healthcare sector especially for pediatric and geriatric patients
We have investigated the development of 3DP multi-compartment oral tablets containing GLMP
Curcumin oil was successfully extracted from the dried rhizomes of curcuma longa
Summary
The ability to tune or tailor a formulation by flexible control of drug formulation, dose and physicochemical properties has a great impact on the healthcare sector especially for pediatric and geriatric patients. This concept is of great importance when the physiology, drug response, and genetic profile of patients are considered [1,2]. An effective technology such as three-dimensional printing which offers the controllable and tunable production of patient-customized and personalized dosage forms is needed [4]. Personalized medicine is a promising strategy that is more safe, efficacious, cost effective, and leads to enhancement in patient compliance [5]
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