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Application of Polyethylene glycol 6000 in Protection of Amorphous Form of Piroxicam during Compression.
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| Author:
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UPLOADED BY-ADMIN, R. P. PATEL, A. M. SUTHAR, M P PATEL, A H BARIA
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| Abstract:
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The purpose of the study was to evaluate the polymorphic transition and stability problems
during amorphous drug formulation. To assess the ability of Polyethylene glycol – 6000
(PEG 6000) in protection of amorphous form of drug during compression and shelf life with
lower proportion. Amorphous piroxicam (APX) was prepared by spray drying technique.
Tablets of APX and melt granules of APX (MG-APX) with PEG 6000 were prepared. Tablets
parameters like hardness, friability, disintegration and content uniformity were evaluated.
Drug-polymer interactions were characterized by using differential scanning calorimetry
(DSC) study. Tablets were evaluated immediately after compression and on storage for 3
months at ambient conditions to determine degree of transformation using DSC and dissolution
profiles. Spray drying yielded the amorphous piroxicam. Content uniformity in the tablet
was in between 96 to 104%. Other parameters like disintegration and hardness were well
within the limits. The results showed significant difference in the degree of dissolution between
APX tablet and MG-APX tablet. This might be attributed to the presence of excipient,
which aided the dispersibility of the APX and MG-APX. MG-APX tablet showed no change
in dissolution behavior after 3 months storage due to formation of hydrogen bonding between
the PEG 6000 and APX that may maintain its amorphous form. Also PEG 6000 can be tableted
very easily under low pressure and showed elastic recovery. PEG 6000 yielded a soft
embedding during tableting, which prevented the polymorphic transformation. PEG 6000 are
able to protect amorphous piroxicam during compression.
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| Keyword:
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melt granulation; amorphous; stabilization; compression
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| EOI:
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| DOI:
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