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Abstract
The purpose of the study was to develop a novel, directly compressible, co-processed excipient capable of providing a controlled-release drug system for the pharmaceutical industry. A co-processed powder was formed by adsorption of solid lipid nanoparticles (SLN) as a controlled-release film onto a functional excipient, in this case, dicalcium phosphate dihydrate (DPD), for direct compression (Di-Tab®). The co-processed excipient has advantages: easy to implement; solvent-free; industrial scaling-up; good rheological and compressibility properties; and the capability to form an inert platform. Six different batches of Di-Tab®:SLN weight ratios were prepared (4:0.6, 3:0.6, 2:0.6, 1:0.6, 0.5:0.6, and 0.25:0.6). BCS class III ranitidine hydrochloride was selected as a drug model to evaluate the mixture’s controlled-release capabilities. The co-processed excipients were characterized in terms of powder rheology and dissolution rate. The best Di-Tab®:SLN ratio proved to be 2:0.6, as it showed high functionality with good flow and compressibility properties (Carr Index = 16 ± 1, Hausner Index = 1.19 ± 0.04). This ratio could control release for up to 8 h, so it fits the ideal profile calculated based on biopharmaceutical data. The compressed systems obtained using this powder mixture behave as a matrix platform in which Fickian diffusion governs the release. The Higuchi model can explain their behavior.
Highlights
The preference for manufacturing tablets as a controlled-release drug system can be enhanced by incorporating new materials into the compression process
The polydispersity index (PDI) was narrow for all the batches with values of 0.29 ± 0.05, indicating a homogeneous particle size distribution. These results show a smaller particle size and PDI than those reported by Martinez-Acevedo et al [24] for Compritol® 888 ATO solid lipid nanoparticles (SLN) using polyvinyl alcohol as the stabilizer and the hot dispersion method, and are consistent with those reported by Swapnil-Kumar et al [25] for Compritol® 888 ATO SLN loaded with ritonavir and prepared by the solvent evaporation method
These results show that the co-processed excipients elaborated in this study form compact platforms by direct compression, in potential chemical gradient. These results are consistent with the Higuchi model (r2 0.9892), which establishes a KH value of 32.98. These results show that the co-processed excipients elaborated in this study form compact platforms by direct compression, in which the SLN
Summary
The preference for manufacturing tablets as a controlled-release drug system can be enhanced by incorporating new materials into the compression process. The directcompression process’s simplicity and cost-effectiveness have positioned it as an alternative to the traditional granulation technology [1,2,3]. The success of this process is critically affected by the powder’s behavior in terms of flowability and compressibility [4]. HFI can be obtained through various means: developing new chemical formulations, enhancing existing ones, or elaborating new combinations of existing excipients [7]. Developing new chemical excipients entails significant economic and operational challenges related to safety and regulatory norms [8]
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