Formulation Optimization of Selective Laser Sintering 3D-Printed Tablets of Clindamycin Palmitate Hydrochloride by Respo
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Research Article Formulation Optimization of Selective Laser Sintering 3D-Printed Tablets of Clindamycin Palmitate Hydrochloride by Response Surface Methodology Eman M. Mohamed,1,2 Sogra F. Barakh Ali,1 Ziyaur Rahman,1 Sathish Dharani,1 Tanil Ozkan,3 Mathew A. Kuttolamadom,4 and Mansoor A. Khan1,5
Received 21 March 2020; accepted 27 July 2020 Abstract.
The aims of the current study were to develop and evaluate clindamycin palmitate hydrochloride (CPH) 3D-printed tablets (printlets) manufactured by selective laser sintering (SLS). Optimization of the formulation was performed by studying the effect of formulation and process factors on critical quality attributes of the printlets. The independent factors studied were laser scanning speed, microcrystalline cellulose (MCC), and lactose monohydrate (LMH) concentration. The responses measured were printlets weight, hardness, disintegration time (DT), and dissolution in 30 min. The printlets were characterized for content uniformity, chemical interactions, crystallinity, drug distribution, morphology, and porosity. The laser scanning speed showed statistically significant effects on all the studied dependent responses (p < 0.05). MCC showed statistically significant effects on hardness, DT, and dissolution (p < 0.05), while LMH showed statistically significant effect on hardness and dissolution (p < 0.05). The model was validated by an independent formulation, and empirical values were in close agreement with model-predicted values. X-ray powder diffraction and differential scanning calorimetry data suggested a decrease in crystallinity of the LMH in the printlets. X-ray micro-CT scanning showed porous microstructure of the printlets with a porosity 24.4% and 31.1% for the printlets printed at 200 and 300 mm/s laser speed, respectively. In summary, the SLS method provides an opportunity to fabricate customized dosage forms as per patients’ need. KEY WORDS: 3D printing; clindamycin palmitate hydrochloride; selective laser sintering; BoxBehnken; X-ray micro-CT; NIR-chemical imaging; dissolution.
INTRODUCTION Patient-centeric dosage forms can be achieved through application of 3D printing (3DP) (1). The technology allows individualization of medicine based on patients’ need and intended therapeutic outcome (2,3). In 3DP, dose can be controlled by calculating material consumption, numbers of printed layers, and resizing of the printed object (4). It is also possible to fabricate polypill containing number of drugs with varying dissolution profiles (5–7).
1
Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, Texas 77843, USA. 2 Department of Pharmaceutics, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, 62514, Egypt. 3 Dover Precision Components, Woodlands, Texas, USA. 4 Department of Engineering Technology & Industrial Distribution, College of Engineering, Texas A&M University, College Station, Texas 77843, USA. 5 To whom correspondence should be addressed. (e–mail: [email protected])
Many 3DP methods have been
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