Kollicoat IR®, a new pharmaceutical excipient developed as a coating polymer for instant release tablets, was evaluated as a carrier in solid dispersions of. Kollicoat® IR, a graft copolymer comprised of polyethylene glycol and polyvinyl alcohol (PEG: PVA, ), has been used as an instant release. Cech T., Kolter K. , Influence of plasticizer on the film properties of HPMC and PVA and comparison of the results with the properties of Kollicoat® IR as.
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Highly flexible film thanks to integrated plasticizer. Brochure Ensuring the precision you need — every time: Cookies help us deliver our services. This study also provides an understanding on controlling the degradation of raloxifene and other drugs alike highly sensitive to peroxides by selecting the appropriate binders or excipients lacking residual peroxides.
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Unless noted otherwise, the statistical analysis was not performed as all the data points were a single measurement on each individual samples. The oxidative degradation of raloxifene to N-oxide is shown in Figure 3.
Taken collectively, the data suggest that PEG-PVA exceptionally performed as a wet binder in fluid bed and high shear granulations, and the compression profiles of resulting granules were similar to those obtained with copovidone, HPMC and povidone K Based on a work at https: Granule properties such as particle size and compression profile were evaluated, and compared with copovidone and HMPC granules. The data from this study demonstrates that PEG-PVA, lacking the inherent residual peroxides as shown in Table 4, curtails the oxidative degradation of raloxifene in the tablets.
Thus, minimizing the risks for elevated impurities in the excipients, especially the peroxides, is highly essential, which could otherwise be detrimental to long term stability of pharmaceutical dosages [5 6].
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Taken collectively, this study also demonstrates that PEG-PVA was exceptionally stable and did not show a peroxide increase under the various ambient stability conditions over a 5 years period. Industry Please choose your industry. ie
Binders are important ingredients of solid oral dosage formulations SODFs. In a matrix dosage wherein the drugs and excipients typically are intimately in contact, an elevated level of peroxide may lead to significant oxidation of sensitive drugs, especially those bearing tertiary amines and secondary alcohols.
Due to its low viscosity values in aqueous solutions, easy processing in a vast process parameter range is assured. Wet binder in formulation of ascorbic acid tablet The properties of PEG-PVA as a binder have been evaluated in wet and fluid bed granulations . Oxidative degradation of raloxifene may lead to adverse reactions .
Edmond, OK Tel: The aim of this study was to investigate the peroxide free instant release polymer in the instant release matrix tablet and examine the oxidative degradation of raloxifene when used as a wet binder.
Therefore, the efforts continue to jollicoat the appropriate excipients lacking peroxides, or having significantly low peroxides to alleviate the oxidative degradation.
Kollicoat® IR: Minimizing the Risks for Oxidative Degradation of Drugs
In the high shear mixing, the granules however were densely packed, less porous, and hence were less compressible. Please retry again later.
Please choose your country. We will save your personal data only as long as necessary to respond to your requests. Compression profiles of ascorbic acid tablets prepared from the granules prepared by fluid bed and high shear granulations; the compressions were carried out on each individual samples, hence no statistical data. Please try again later.
Tablet properties such as tablet weight, thickness, hardness, friability, and disintegration time with PEG-PVA and povidoneK30 were evaluated and found to be comparable with both binders with the individual corresponding amounts used. This study is aimed at examining the impact okllicoat peroxides on degradation of drug in formulations prepared by wet granulation and finds the id excipients to mitigate the risks for degradation.
Stability condition 3 mo. Please check your mailbox for further information.