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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Please retry again later. Highly reliable, cost-effective processes that produce first-class results every time. Binders are important kolkicoat of solid oral dosage formulations SODFs. Cookies help us deliver our services.
Thus, controlling these impurities is important in alleviating the degradants to enhance the shelf life of drug products. 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.
Oxidative degradation has been studied extensively . The aim of this study was to if 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. The possibilities include the use of antioxidants or smart packaging to alleviate the oxidative degradation [19,20].
HelloYou are logged in with access to additional information. J Anal Pharm Res 2 3: Due to its low viscosity values in aqueous solutions, easy processing in a vast process parameter range is assured.
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Country Please choose your country. 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. 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.
Please check your mailbox for further information. 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 of peroxides on degradation of drug in formulations prepared by wet granulation and finds the appropriate excipients to mitigate the risks for degradation. Oxidative degradation of raloxifene may lead to adverse reactions . 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.
The data also demonstrate that the fluid bed granules were highly compressible as compared to those prepared kolicoat high shear granulation due to high porosity. Portfolio Overview Focusing on your needs with platform solutions Read. The stability of active ingredients depends on external factors, e.
The oxidative degradation of raloxifene to N-oxide is shown in Figure 3. Based on a work at https: We will save your personal data only as long as necessary to respond to your requests. Poster Evaluating iir wet binders to gain lactose based agglomerates applicable for ODT Download.
These peroxides not only limited to binders and disintegrants such as povidone and crospovidone but to other ingredients such as fillers, lubricants and surfactants, can also cause oxidative degradation of sensitive drugs. 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 .
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 MedCrave Group Danforth Rd. Subindustry Please choose your subindustry.
A further study suggests that the formation of N-oxide was not limited to formulation only but was also observed in the synthesis of raloxifene . In the high shear mixing, the granules however were densely packed, less porous, and hence were less compressible. Oxidative degradation of raloxifene. As wet binderit provides high binding efficiency. Please try again later. Highly flexible film thanks to integrated plasticizer.
Therefore, the efforts continue to identify 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
If you register for a newsletter, you can unsubscribe at any time. This water-soluble film-forming agent is ideal for manufacturing instant-release coatings for solid dosage forms — and for applications such as bindingpore forming and drug layering. Please choose irr subindustry. Please provide a valid registered E-Mail ID. Visit our Download Center.
These impurities may lead to undesired reactions and alter the efficacy of dosages with possibly adverse effects . The stability data, as shown in Table 5, suggests that raloxifene tablets with PEG-PVA were stable over 6 month period without degradation.
Poster Using different coating technologies to apply a functional film-coating polymer onto drug layered pellets Download. Your personal data might be passed on to affiliated companies or third parties.
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. Stability condition 3 mo. Those residual peroxides typically originate during the manufacturing process and get carried over practically in many of the excipients used in formulation.
Back to registration form. The stability data reveal that the peroxide level does not increase at ambient and accelerated stability conditions.