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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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By using our services, you agree to our use of cookies. This study also provides an understanding on controlling the degradation of raloxifene and kollicoat drugs alike highly sensitive to peroxides by selecting the appropriate binders or excipients lacking residual peroxides.

Highly reliable, cost-effective processes that produce first-class results every time. Your personal data might be passed kollocoat to affiliated companies or third parties.

Subindustry Please choose your subindustry. 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 kollicowt. This graft copolymer with a low viscosity provides additional advantages in other applications such as instant release coating, emulsifier, wetting agent and hydrophilic pore former in sustained release tablets.

Please provide your registered UserId to reset your password. 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 kollicota obtained with copovidone, HPMC and povidone Kollicoah Oxidative degradation has been studied extensively [].

The possibilities include the use of antioxidants or smart packaging to alleviate the oxidative degradation [19,20]. Link to reset your password has been sent to your provided E-Mail ID. Based on a work at https: Kolllicoat, 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 ur.


Please retry again later. Brochure Ensuring the precision you need — every time: Visit our Download Center. Highly flexible film thanks to integrated plasticizer. The stability of active ingredients depends on external factors, e. 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 stability data, as shown in Table 5, suggests that raloxifene tablets with PEG-PVA were stable over 6 month period without degradation. Keep me logged in.

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

Peroxides, amongst many of the impurities, remain the most challenging in drug development. Such processing steps can lead to elevated impurity levels. For instance, wet granulation though remains widely practiced in the industry for its kollicozt 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].

Therefore, the efforts continue to identify the appropriate excipients lacking peroxides, or having significantly low peroxides to alleviate the oxidative degradation. Poster Evaluating various wet binders koolicoat gain lactose based agglomerates applicable for ODT Download.

Please choose your subindustry. 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. As wet binderit provides high binding efficiency.

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 lollicoat prone to oxidative degradation.

HelloYou are logged in with access to additional information. Stability condition 3 mo. The data also demonstrate that the fluid bed granules were highly compressible as compared to those prepared by high shear granulation due to high porosity. The oxidative degradation of raloxifene to N-oxide is shown in Figure 3.


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Granule properties such as particle size and compression profile were evaluated, and compared with copovidone and HMPC granules.

Binders and their peroxide levels in raloxifene tablets. 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.

In the high shear mixing, the granules however were densely packed, less porous, and hence were less compressible.

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. The hardness of the granules, klolicoat as a function of compression forces in both fluid bed and high shear granulations. In addition, PEG covalently bound to polyvinyl alcohol acts as an internal plasticizer and provides a high flexibility, thus allowing the polymer to overcome the mechanical stress during manufacturing and storage of dosage forms.

PEG-PVA, developed first as an instant release coating polymer for immediate release coatings, has also been used as a hydrophilic pore former in the drug layering for sustained release tablets [10]. Cookies help us deliver our services. 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 lollicoat bearing tertiary amines and secondary alcohols.

Please choose your country. Due to its low viscosity values in aqueous solutions, easy processing in a vast process parameter range is assured. Back to registration form. Edmond, OK Tel: Kollicoar are important ingredients of solid oral dosage formulations SODFs.

The stability data reveal that the peroxide level does not increase at ambient and accelerated stability conditions. Choose your language This site is available in the following languages: