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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Click here to kollicoah your manuscript MedCrave Group Danforth Rd. 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. Choose your language This site is available in the following languages: Stability condition 3 mo.
Subindustry Please choose your subindustry. Please choose your subindustry. 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.
The stability data reveal that the peroxide level does not increase at ambient and accelerated stability conditions.
Oxidative degradation of raloxifene may lead to adverse reactions [18]. As wet binderit provides high binding efficiency. Highly flexible film thanks to integrated plasticizer.
And all those characteristics also make it a great pore former for sustained release formulations. PEG-PVA, developed first as an instant release coating polymer for immediate release coatings, has also been used as a iir pore former in the drug layering for sustained release tablets [10]. Granule properties such as particle size and compression profile were evaluated, and compared with copovidone and HMPC granules.
The hardness of the granules, increased as a function of compression forces in both fluid bed and high shear granulations. In the high shear mixing, the granules however were densely packed, less porous, and hence were less compressible. 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.
Peroxides, amongst many of the impurities, remain the most challenging in drug development. By using our services, you agree to our use of cookies. These impurities may lead to undesired reactions and alter the efficacy of dosages with possibly adverse effects [3].
No part of this content may be reproduced or transmitted in any form or by any means as per the standard guidelines of fair use. Composition of raloxifene tablets. The stability data, as shown in Table 5, suggests that raloxifene tablets with PEG-PVA were stable over 6 month period without degradation.
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. 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.
Edmond, OK Tel: 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. Poster Using different coating technologies to apply a functional film-coating polymer onto drug layered pellets Download.
Kollicoat® IR: Minimizing the Risks for Oxidative Degradation of Drugs
With increasing amounts of peroxides spiked with hydrogen peroxide the formation of N-oxide increased causing a significant loss inpotency of drug [5]. Please choose your country. HelloYou are logged in with access to additional information. 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].
Likewise, the tablets with povidone K30 bearing the low peroxide e. Please provide your registered UserId to reset your password. Industry Please choose your industry. Your personal data might be passed on to affiliated companies or third parties. You will find the unsubscribe link at the end of each newsletter you receive. MedCrave Group is ardent to provide article reprints at an instant affordable Read more Cookies help us deliver our services.
Due to its low viscosity values in aqueous solutions, easy processing in a vast process parameter range is assured. Portfolio Overview Focusing on your needs with platform solutions Read. 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]. The oxidative degradation of raloxifene to N-oxide is shown in Figure 3.
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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. In a subsequent investigation, Yarkala et al. Iollicoat to registration form. 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 stability of active ingredients depends on external factors, e. Based on a work at https: A further study suggests that the kolllicoat of N-oxide was not limited to formulation only but was also observed in the synthesis of raloxifene [17].
Taken collectively, the data suggest that Irr 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