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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Minimizing the Risks for Oxidative Degradation of Kolilcoat. Our data demonstrates that the PEG-PVA as a peroxide-free binder can withstand the robust processing conditions and can minimize the risk of oxidative degradation as evident from the data in Table 5.

Ig 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 Portfolio Overview Focusing on your needs with platform solutions Read.

Thus, PEG-PVA with remarkable properties as binder and coating polymer, and free of peroxides, brings a new generation of excipient that could be widely applied to a range of wet granulation formulation development of highly sensitive drugs prone to oxidative degradation. This study is aimed at examining the impact of peroxides on degradation of drug in formulations prepared by wet granulation and finds the appropriate excipients to mitigate the risks for degradation.

The oxidative degradation of highly sensitive drug as raloxifene and others alike in wet granulation can be minimized during the formulation process by use of PEG-PVA. 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.

Oxidative degradation has been studied extensively []. Based on a work at https: HelloYou are logged in with access to additional information.


Kollicoat® IR: Minimizing the Risks for Oxidative Degradation of Drugs

Those residual peroxides typically originate during the manufacturing process and get carried over practically in many of the excipients used in formulation. Oxidative degradation of raloxifene may lead to adverse reactions [18].

Such processing steps can lead to elevated impurity levels. Industry Please choose your industry. Thus, controlling these impurities is important in alleviating the degradants to enhance the shelf life of drug products.

Likewise, the tablets with povidone K30 bearing the low peroxide e. Link to reset your password has been sent to your provided E-Mail ID. In the high shear mixing, the granules however were densely packed, less porous, and hence were less compressible.

The possibilities include the use of antioxidants or smart packaging to alleviate the oxidative degradation [19,20]. Cookies help us deliver our services.

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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. Back to registration form. Granule properties such as particle size and compression profile were evaluated, and compared with copovidone and HMPC granules. With increasing amounts of peroxides spiked with hydrogen peroxide the formation of N-oxide increased causing a significant loss inpotency of drug [5].

For instance, wet granulation though remains widely practiced in the industry for its simplicity and easy scale up, can exert an enormous mechanical stress on the excipients caused by multiple formulation steps involving blending, mixing, granulation, drying, and sieving [4].

Choose your language This site is available in the following languages: 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.


MedCrave Group is ardent to provide article reprints at an instant affordable Read more The stability of active ingredients depends on external factors, e. If you register for a newsletter, you can unsubscribe at any time. Due to its low viscosity values in aqueous solutions, easy processing in a vast process parameter range is assured.

Raloxifene, bearing a tertiary amine and being highly sensitive to oxidation, has been investigated to demonstrate the feasibility of PEG-PVA as an alternative binder to control oxidative degradation to N-oxide, and perhaps other sensitive drugs alike.

A further study suggests that the formation of N-oxide was not limited to formulation only but was also kollioat in the synthesis of raloxifene [17]. And all those characteristics also make it a great pore former for sustained release formulations.

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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.

Please retry again later. Wet binder in formulation of ascorbic acid tablet The properties of PEG-PVA as a binder have been evaluated in wet and fluid bed id []. In a subsequent investigation, Yarkala et al. Binders and their peroxide levels in raloxifene tablets. Click here to klllicoat your manuscript Subindustry Please choose your subindustry.

Binders are important ingredients of solid oral dosage formulations SODFs. 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. Kollicota our Download Center.

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