Evaluation and comparative studies of the dissolution profiles of gummi armeniacae and PVP-containing Acetaminophen tablets
DOI:
https://doi.org/10.31989/ffhd.v15i10.1732Abstract
Background: Prunus armeniaca gum is a functional food ingredient with beneficial antioxidant properties. As a natural polymer, like different gums, it possesses high binding capacity as well as other pleasing properties like preservatives, fillers, and sustained release. The usage of apricot gum as a food and pharmacy formulation additive provides a more economical option than synthetic polymers like polyvinylpyrrolidone (PVP). Gummi Armeniacae, similar to Gummi Arabica, is widely used as an excipient in the pharmaceutical and food industries.
Objectives: This study aimed to formulate 50 mg acetaminophen tablets using either Gummi Armeniacae or PVP as a binder and compare their dissolution profiles in different media.
Methods: For research purposes, the purified and standardized Gummi Armeniaca collected from the Arzni region was used. Acetaminophen 50 mg, and the PVP or Gummi Armeniacae as a binder, containing tablets, were produced at the “Arpimed” Pharmaceutical LLC. The characterization of the obtained tablets was conducted according to the tablet's USP quality requirements. The dissolution profiles of Acetaminophen 50 mg tablets were carried out according to WHO Guidance (the paddle speed was 75 rpm, the temperature was 37±0.5°C, and the dissolution media volume was 900 mL) in three dissolution media with pH 1.2, 4.5, and 6.8.
Results: At Arpimed Pharmaceutical Company, two series of 50 mg Acetaminophen tablets with two different compositions were produced (PVP K30 and standardized powder of Gummi Armeniacae). The results of general tablet quality testing procedures, including average mass, uniformity of mass, thickness, diameter, assay, friability, and disintegration time, corresponded to USP requirements. PVP and Gummi Armeniacae containing Acetaminophen 50 mg tablets exhibited high solubility in three different (pH 1.2, 4.5, 6.8) dissolution media (≥85% of the labeled amount of drug in 30 minutes). Furthermore, the comparative dissolution profile study indicates that tablets containing Gummi Armeniacae dissolve rapidly in hydrochloric acid media at pH 1.2. Moreover, the rate of acetaminophen dissolution from this formulation decreases as the pH shifts from 1.2 to 6.8.
Conclusions: Tablets containing Gummi Armeniacae as a binder possess pH-dependent drug substance release from tablets. Further studies could recommend it as a bonding excipient for the tablet manufacturing process.
Keywords: Gummi Armeniacae, Acetaminophen tablets, Binder, Dissolution profile, PVP
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