Abstract
Aim: The main aim of the present study was to characterize and perform the compatibility studies of paliperidone with its excipients.
 Study Design: Physico-chemical characterization and compatibility studies.
 Place and Duration of the Study: Chalapathi Drug Testing Laboratory, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur-522034 between December 2020 and January 2021.
 Methodology: Physico-chemical characterization and compatibility studies of paliperidone palmitate with its excipients like HPMC, lactose, magnesium stearate, talc, microcrystalline cellulose was done using the FTIR spectrophotometer, Scanning electron microscopy, X-ray diffraction, Differential scanning calorimeter.
 Results: Interaction of the paliperidone palmitate with its excipients were studied by this technique. Paliperidone palmitate showed the transition at 117.920C with the specific heat of 101.9J/g. The IR spectrum of paliperidone palmitate and excipients mixture has shown a characteristic stronger band of the N-H at 3412.75cm-1, C-H at 2921.98 cm-1, stretching vibrations of C=O at 1737.47 cm-1, C=C at 1651.94 cm-1, N-O at 1541.16 cm-1 followed by C-F at 1160.46 cm-1. XRD showed good crystalline properties with relative crystallinity index of 60.01%. The photomicrographs obtained by SEM did not evidence any interaction between paliperidone palmitate and the excipients, providing visual support for the results.
 Conclusion: There were no interactions of drug with selected excipients and found to be compatible. Therefore, it is a mandatory clause for the compound compatibility with various excipients in the formulation which affect the stability and efficacy of the formulation.
Highlights
IntroductionThe chemical name is (9RS)-3-[2-[4-(6-fluoro-1,2benzisoxazol-3-yl) piperidin-1-yl] ethyl] -2methyl4-oxo-6,7,8,9-tetrahydro- 4H -pyrido [1,2a] pyrimadin-9-yl hexadecanoate
XRD was used in knowing the crystal structure and properties of the molecule and lattices in the molecule, whereas scanning electron micros copy (SEM) was used to identify problems with particle size and shape of the molecule [12,13]
Paliperidone palmitate bulk material was procured from Merck
Summary
The chemical name is (9RS)-3-[2-[4-(6-fluoro-1,2benzisoxazol-3-yl) piperidin-1-yl] ethyl] -2methyl4-oxo-6,7,8,9-tetrahydro- 4H -pyrido [1,2a] pyrimadin-9-yl hexadecanoate. The molecular formula of paliperidone palmitate is C39H57FN4O4 and its molecular weight is 664.89. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol and slightly soluble in ethyl acetate [1,2]. Infrared spectrophotometer is used for the characterization of the compounds and excipients [9,10,11]. It is done based on the analysis of functional groups present in the compound and in excipients. XRD was used in knowing the crystal structure and properties of the molecule and lattices in the molecule, whereas SEM was used to identify problems with particle size and shape of the molecule [12,13]
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