Abstract
Glimepiride is characterized by an inconsistent dissolution and absorption profile due to its limited aqueous solubility. The aim of this study was to develop glimepiride tablets using three different manufacturing techniques, as well as to study their quality attributes and pharmacokinetics behavior. Black seed oil based self-nanoemulsifying drug delivery system (SNEDDS) formulation was developed and characterized. Glimepiride liquisolid and directly compressed tablets were prepared and their pre-compression and post-compression characteristics were evaluated. Semi-solid pastes loaded with SNEDDS were prepared and used to develop three-dimensional printing tablets utilizing the extrusion technique. In vivo comparative pharmacokinetics study was conducted on Male Wistar rats using a single dose one-period parallel design. The developed SNEDDS formulation showed a particle size of 45.607 ± 4.404 nm, and a glimepiride solubility of 25.002 ± 0.273 mg/mL. All the studied tablet formulations showed acceptable pre-compression and post-compression characteristics and a difference in their in vitro drug release behavior. The surface of the liquisolid and directly compressed tablets was smooth and non-porous, while the three-dimensional printing tablets showed a few porous surfaces. The inner structure of the liquisolid tablets showed some cracks and voids between the incorporated tablet ingredients while that of the three-dimensional printing tablets displayed some tortuosity and a gel porous-like structure. Most of the computed pharmacokinetic parameters improved with the liquisolid and three-dimensional printed tablets. The relative bioavailabilities of the three-dimensional printed and liquisolid tablets compared to commercial product were 121.68% and 113.86%, respectively. Therefore, the liquisolid and three-dimensional printed tablets are promising techniques for modifying glimepiride release and improving in vivo performance but more clinical investigations are required.
Highlights
To overcome glimepiride poor aqueous solubility, limited dissolution in the gastrointestinal fluids and to avoid dose dumping, we have developed a black seed oil based-self-nanoemulsifying drug delivery system (SNEDDS) formulation and used this formulation to prepare liquisolid and 3D-printed tablets
SNEDDS is characterized by its ability to enhance the solubility, dissolution and absorption of many hydrophobic drugs in the gastrointestinal tract since it is self-emulsify quickly in the stomach aqueous contents and so introduces the loaded drug in solution within nano-sized oil droplets [21,22,23]
As a result of this behavior, the surface area and size of oil droplets that are digested are increased, and they are incorporated into mixed micelles that can pass through the intestinal lumen [24]
Summary
Oral solid dosage forms, especially tablets, are the most popular among all administered medicines. Oral tablets are commonly prepared utilizing wet granulation, dry granulation or direct compression [1]. The freeze-drying technique has been utilized to develop oral tablets [2,3]. The most considerable drawbacks of these techniques are their inability to modify the dosage form to produce a complex multi-component system that meets individual needs in therapeutic regimens [4]. Three-dimensional printing has been employed to develop dosage forms with single and multi-drug systems [4,5,6]. It is a manufacturing platform that holds a great promise in fabricating active pharmaceutical
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