Abstract
Low-dose tablet formulations were produced with excellent homogeneity based on drug-loaded electrospun fibers prepared by single-needle as well as scaled-up electrospinning (SNES and HSES). Carvedilol (CAR), a BCS II class compound, served as the model drug while poly (vinylpyrrolidone-co-vinyl acetate) (PVPVA64) was adopted as the fiber-forming polymer. Scanning electron microscopy (SEM) imaging was used to study the morphology of HSES and SNES samples. Different homogenization techniques were compared to maximize homogeneity: mixing in plastic bags and in a high-shear granulator resulting in low-shear mixing (LSM) and high-shear mixing (HSM). Drug content and homogeneity of the tablets were measured by UV-Vis spectrometry, the results revealed acceptably low-dose fluctuations especially with formulations homogenized with HSM. Sieve analysis was used on the final LSM and HSM powder mixtures in order to elucidate the observed differences between tablet homogeneity. Tablets containing drug-loaded electrospun fibers were also studied by Raman mapping demonstrating evenly distributed CAR within the corpus.
Highlights
Tablets are generally regarded as the most popular and accepted dosage forms in pharmaceutical technology
content uniformity (CU) was evaluated by UV-Vis spectrometry, while active pharmaceutical ingredients (APIs) distribution in the tablets was studied with Raman mapping and final powder mixture homogeneity was evaluated by sieve analysis
To evaluate the homogeneity differences between low-shear mixing (LSM) and high-shear mixing (HSM) ES tablets, Raman maps were taken of the aforementioned solid dosage forms
Summary
Tablets are generally regarded as the most popular and accepted dosage forms in pharmaceutical technology. Their ease of manufacturing and high patient compliance make them an ideal choice for both the industry and therapeutics [1]. Tablets are available with doses ranging from very low (micrograms) to very high (1–2 g). In such extreme cases, manufacturing becomes more challenging which is especially true for microgram dosed formulations. Proper content uniformity (CU) among others is one of the basic requirements of tablets by Pharmacopeias across the world [3] ensuring high quality and patient safety
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