Abstract
The 3D printing techniques have been explored extensively in recent years for pharmaceutical manufacturing and drug delivery applications. The current investigation aims to explore 3D printing for the design and development of a nanomedicine-based oral solid dosage form of a poorly water-soluble drug. A self-nanoemulsifying tablet formulation of dapagliflozin propanediol monohydrate was developed utilizing the semisolid pressure-assisted microsyringe (PAM) extrusion-based 3D printing technique. The developed formulation system consists of two major components (liquid and solid phase), which include oils (caproyl 90, octanoic acid) and co-surfactant (PEG 400) as liquid phase while surfactant (poloxamer 188) and solid matrix (PEG 6000) as solid-phase excipients that ultimately self-nanoemulsify as a drug encapsulated nanoemulsion system on contact with aqueous phase/gastrointestinal fluid. The droplet size distribution of the generated nanoemulsion from a self-nanoemulsifying 3D printed tablet was observed to be 104.7 ± 3.36 nm with polydispersity index 0.063 ± 0.024. The FT-IR analysis of the printed tablet revealed that no drug-excipients interactions were observed. The DSC and X-RD analysis of the printed tablet revealed that the loaded drug is molecularly dispersed in the crystal lattice of the tablet solid matrix and remains solubilized in the liquid phase of the printed tablet. SEM image of the drug-loaded self-nanoemulsifying tablets revealed that dapagliflozin propanediol monohydrate was completely encapsulated in the solid matrix of the printed tablet, which was further confirmed by SEM-EDS analysis. The in vitro dissolution profile of dapagliflozin-loaded self-nanoemulsifying tablet revealed an immediate-release drug profile for all three sizes (8 mm, 10 mm, and 12 mm) tablets, exhibiting >75.0% drug release within 20 min. Thus, this study has emphasized the capability of the PAM-based 3D printing technique to print a self-nanoemulsifying tablet dosage form with an immediate-release drug profile for poorly water-soluble drug.
Highlights
This study demonstrated a proof-of-concept that a 3D printing technique can be utilized to develop solid self-emulsifying drug delivery systems without using solid adsorbents to convert the liquid self-emulsifying formulation system into patient-tailored oral solid dosage forms
The spontaneous nanoemulsion formation of a selfnanoemulsifying drug delivery systems (SNEDDS) is facilitated by the addition of a co-surfactant to the system, which helps to minimize the interfacial tension between the aqueous and oily phases [28,29]
188, which acts as a surfactant and solidifying further extends the line of research carried out in the area of SNEDDS-based pharmaceuagent has led to the development of a solid self-nanoemulsifying tablet without using an tical product development
Summary
Pharmaceutics 2021, 13, 993 approach that consists of drug molecularly dispersed in the isotropic mixture of oil, surfactant, and co-surfactant [6] It forms a stable nanoemulsion system in contact with the aqueous phase upon oral administration. The liquid formulations are associated with various limitations, including dose uniformity, low stability, and interaction of the liquid formulation with the capsule shell may lead to softening/brittleness of shell or change in taste perception or leakage of liquid from the filled capsule [8] These limitations have restricted the industrial product development of liquid SNEDDS and have given a combusting interest to transform these liquid SNEDDS formulations into a solid self-nanoemulsifying dosage form. The various attempts explored to develop solid SNEDDS formulations include adsorption of liquids on solid carriers [9], spray drying and spray cooling [10,11], and extrusion/spheronization for pellet design [12]
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