| บทคัดย่อ |
Two key properties of excipients for inclusion in direct compression tablets are flowability and
compactibility. Glutinous rice starch (GRS) has poor flowability, which limits its use in direct
compression tablets. This study aimed to create a multifunctional direct compression excipient
(filler binder disintegrant) with improved flowability from GRS by the co-precipitation method.
The physicochemical and pharmaceutical properties of the co-precipitated GRS (cpGRS) were
investigated. The optimum conditions for producing cpGRS (0.43 M sodium hydroxide solution,
7.09% PVP K30, 14.02% calcium carbonate, 95 min of mixing time and pH of 6.97) resulted in
68.80% yield, fair to good flowability, acceptable tablet strength, and fast disintegration. The FTIR spectra of cpGRS showed no significant shifts in the key peaks, which indicates that there was
an absence of chemical interactions within cpGRS. X-ray diffractograms also showed no significant changes, indicating that the GRS granules, calcium carbonate, and PVP K30 components
remained unaltered during co-precipitation. cpGRS also demonstrated a dilution capacity of 50%
when paracetamol was used as model drug. When cpGRS was combined with domperidone or
propranolol hydrochloride it showed a better deformation capability than the physical mixtures.
Although cpGRS was sensitive to lubricant, the hardness and tensile strength were higher than
common strength for general purpose use in tablets. When compared to the physical mixture,
pregelatinized starch and directly compressible calcium carbonate, the results showed that cpGRS
tablets of both model drugs passed the friability test, demonstrated the best disintegration
property, provided the fastest and highest drug release profile for propranolol, and improved the
drug release profile for domperidone. For propranolol-cpGRS tablets, dissolution medium at
different pH did not affect the dissolution profile. For domperidone-cpGRS tablets, the pH of
dissolution medium did affect the dissolution profile of the tablets. This was according to the API
solubility. These results reveal that cpGRS is an excellent multifunctional i.e., filler, binder, and
disintegrant excipient suitable for direct compression tablets. The main component is natural. The
preparation method is simple, quick, and efficient. This method does not produce harmful waste
and requires only basic equipment, and affordable reactants and devices. |
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