Drying of Biopharmaceuticals: Recent Developments, New Technologies and Future Direction (original) (raw)
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Future Journal of Pharmaceutical Sciences
Background Process intensification is a major hurdle in pharmaceutical process scale-up. Solvent removal strategies have limited the effectiveness of the overall stability of pharmaceutical formulations. The main aim of present review article is to focus on the use of the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanoderived therapeutics and their translation into commercial viable products. Unwavering efforts of scientists in the process intensification of lyophilization promote unique features of products for commercialization. Regulatory agencies are promoting the utilization of a quality-by-design approach to improve product characteristics. Among 300 FDA-approved pharmaceutical industries, 50% of products are freeze-dried. The freeze-drying process is costlier and requires more time than other drying methodologies. Unstable pharmaceutical dispersions and solutions can be preferably stabilized by using the freeze-drying method. Main text This review highli...
2013
Freeze-drying is a method of removing water by sublimation of ice crystals from frozen material. Suitable parameters of process application allow us to obtain best quality products compared to products dried with traditional methods. In pharmaceutical field lyophilization has become important subject to ongoing development and its expansion. Lyophilization is common, but cost intensive and hence one of the key objectives during freeze-drying process development is to minimize the drying time (mainly primary drying time, which is the longest of the three steps in freeze-drying). However, increasing the shelf temperature into secondary drying before all of the ice is removed from the product will likely cause collapse or eutectic melt. Thus, from product quality as well as process economics standpoint, it is very critical to detect the end of primary drying. This review focused on the recent advances and its targets in near future. At first, the principle, steps involved, formulation ...
Beyond freeze-drying of biologics: vacuum-foam drying and spray freeze-drying
Proceedings of 21th International Drying Symposium, 2018
The complexity of biotherapeutics in development continues to increase as our capability in discovery and recombinant technology improves. While safety and efficacy remain the two critical aspects of all therapeutics, ensuring adequate stability is a challenge. Freeze-drying is a commonly-used processing technique to enhance the stability of biotherapeutic products, although the lengthy process time and low energy efficiency have led to the search for, and evaluation of, next-generation drying technologies, including spray freeze-drying and vaccum-foam drying. Both processes result in dosage forms that vary considerably from those produced by lyophilization and possess physical properties that may be deemed superior for their intended applications. Keywords: vacuum-foam drying; spray freeze-drying; lyophilization; biotherapeutics; stabilization
Journal of Pharmaceutical Investigation
Background Most biopharmaceuticals are developed in liquid dosage forms that are less stable than solid forms. To ensure the stability of biopharmaceuticals, it is critical to use an effective drying technique in the presence of an appropriate stabilizing excipient. Various drying techniques are available for this purpose, such as freeze drying or lyophilization, spray drying, spray freeze-drying, supercritical fluid drying, particle replication in nonwetting templates, and fluidized bed drying. Area covered In this review, we discuss drying technologies and their applications in the production of stable solid-state biopharmaceuticals, providing examples of commercially available products or clinical trial formulations. Alongside this, we also review how different analytical methods may be utilized in the evaluation of aerosol performance and powder characteristics of dried protein powders. Finally, we assess the protein integrity in terms of conformational and physicochemical stability and biological activity. Expert opinion With the aim of treating either infectious respiratory diseases or systemic disorders, inhaled biopharmaceuticals reduce both therapeutic dose and cost of therapy. Drying methods in the presence of optimized protein/stabilizer combinations, produce solid dosage forms of proteins with greater stability. A suitable drying method was chosen, and the process parameters were optimized based on the route of protein administration. With the ongoing trend of addressing deficiencies in biopharmaceutical production, developing new methods to replace conventional drying methods, and investigating novel excipients for more efficient stabilizing effects, these products have the potential to dominate the pharmaceutical industry in the future.
A Review on Freeze Drying Process of Pharmaceuticals
Freeze-drying is a method of removing water by sublimation of ice crystals from frozen material. Suitable parameters of process application allow us to obtain best quality products compared to products dried with traditional methods. In pharmaceutical field lyophilization has become important subject to ongoing development and its expansion. Lyophilization is common, but cost intensive and hence one of the key objectives during freeze-drying process development is to minimize the drying time ( mainly primary drying time, which is the longest of the three steps in freeze-drying). However, increasing the shelf temperature into secondary drying before all of the ice is removed from the product will likely cause collapse or eutectic melt. Thus, from product quality as well as process economics standpoint, it is very critical to detect the end of primary drying. This review focused on the recent advances and its targets in near future. At first, the principle, steps involved, formulation aspects and importance of lyophilization, methods of lyophilization with detection of end point in lyophilization was explained.
Drying Technologies for the Stability and Bioavailability of Biopharmaceuticals
Pharmaceutics, 2018
Solid dosage forms of biopharmaceuticals such as therapeutic proteins could provide enhanced bioavailability, improved storage stability, as well as expanded alternatives to parenteral administration. Although numerous drying methods have been used for preparing dried protein powders, choosing a suitable drying technique remains a challenge. In this review, the most frequent drying methods, such as freeze drying, spray drying, spray freeze drying, and supercritical fluid drying, for improving the stability and bioavailability of therapeutic proteins, are discussed. These technologies can prepare protein formulations for different applications as they produce particles with different sizes and morphologies. Proper drying methods are chosen, and the critical process parameters are optimized based on the proposed route of drug administration and the required pharmacokinetics. In an optimized drying procedure, the screening of formulations according to their protein properties is perfor...
Journal of Pharmaceutical Sciences, 2001
In a companion paper we show that the freezing of samples in vials by shelf-ramp freezing results in significant primary drying rate heterogeneity because of a dependence of the ice crystal size on the nucleation temperature during freezing.1 The purpose of this study was to test the hypothesis that post-freezing annealing, in which the product is held at a predetermined temperature for a specified duration, can reduce freezing-induced heterogeneity in sublimation rates. In addition, we test the impact of annealing on primary drying rates. Finally, we use the kinetics of relaxations during annealing to provide a simple measurement of Tg′, the glass transition temperature of the maximally freeze-concentrated amorphous phase, under conditions and time scales most appropriate for industrial lyophilization cycles. Aqueous solutions of hydroxyethyl starch (HES), sucrose, and HES:sucrose were either frozen by placement on a shelf while the temperature was reduced (“shelf-ramp frozen”) or by immersion into liquid nitrogen. Samples were then annealed for various durations over a range of temperatures and partially lyophilized to determine the primary drying rate. The morphology of fully dried liquid nitrogen-frozen samples was examined using scanning electron microscopy. Annealing reduced primary drying rate heterogeneity for shelf-ramp frozen samples, and resulted in up to 3.5-fold increases in the primary drying rate. These effects were due to increased ice crystal sizes, simplified amorphous structures, and larger and more numerous holes on the cake surface of annealed samples. Annealed HES samples dissolved slightly faster than their unannealed counterparts. Annealing below Tg′ did not result in increased drying rates. We present a simple new annealing–lyophilization method of Tg′ determination that exploits this phenomenon. It can be carried out with a balance and a freeze-dryer, and has the additional advantage that a large number of candidate formulations can be evaluated simultaneously. © 2001 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 90:872–887, 2001
LYOPHILIZATION -PROCESS AND OPTIMIZATION FOR PHARMACEUTICALS
In this 21 st century, Lyophilization emerges to be a novel trend for the drying of pharmaceuticals and biological that are thermolabile or are unstable in aqueous form but stable for longer periods in their dried form. This article provides an overview on the process of lyophilization, how the freeze drying cycle is designed, discussing several important parameters which are important for understanding of this process as well as their role in the designing of an optimized freeze drying cycle, so that a robust and economical process of lyophilization can be developed which does not impact the product quality. It also describes the use of this process in various industries.
Journal of Pharmaceutical Sciences, 2019
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Drying and Dehydration Technologies: A Compact Review on Advance Food Science
MOJ Food Processing & Technology, 2018
Foods grown from the ground are critical wellsprings of fundamental dietary supplements, for example, vitamins, minerals and fiber. Since the dampness substance of new foods grown from the ground is over 80%, they are delegated profoundly perishable wares. Keeping the product fresh is the best way to keep up its wholesome esteem, yet most storage techniques require low temperatures, which are difficult to maintain all through the distribution/supply chain. Then again, drying is an appropriate option for post-harvesting particularly in South-Asian countries like Bangladesh, India, and China etc. where exists ineffectively established low temperature dispersion and handling options. It is reported that more than 20% of the world perishable food products are dried to increase shelf-life of realistic usability and advance food security [1]. Organic products, vegetables and their items are dried to improve capacity dependability, limit bundling prerequisites and diminish transport weight. Regardless, in India scarcely any segment of perishables are dried which prompts huge misfortune as far as cash and work other than soak ascend in costs of wares amid the off season. Drying of foods grown from the ground has been essentially expert by convective drying [2]. There are various investigations that have tended to the issues related with ordinary convective drying. Some essential physical properties of the items have changed, for example, loss of shading, difference in surface, concoction changes influencing flavor and supplements and shrinkage [3]. Plus, convective drying gives little extension for earlier re-hydration to additionally preparing subsequent to drying for a negligible quality [4]. The high temperature of the drying procedure is an imperative reason for loss of value. Bringing down the procedure temperature has extraordinary potential for enhancing the nature of dried items [5,6]. However in such conditions, the working time and the related cost end up noticeably unsuitable. To lessen the operational cost distinctive pre-medicines and new strategy for low temperature and low energy drying techniques are developed. A concise audit of late improvement (recent years) will be talked about in the accompanying areas.