Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals (original) (raw)
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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...
Drying Technology
Spray-drying is an inherently continuous and well-established industrial drying process. It can accelerate manufacturing of biopharmaceuticals and vaccine products, resulting in both an economic and health benefit. In this review, we cover a systematic assessment and discuss the spray-drying of diverse protein pharmaceuticals and excipients included therein, solvent systems applicable to these formulations, equipment used and, respective process parameters. Further, key quality aspects of spray-dried protein solids are discussed. Based on the overall trends, we present a concise perspective into the future of protein pharmaceuticals spray-drying.
Drying of Biopharmaceuticals: Recent Developments, New Technologies and Future Direction
Japan Journal of Food Engineering, 2018
The dehydration of biopharmaceutical products through dr ying provides numerous benefits, including ease of handling and storage, reduction in transportation costs, and improved stability. Typically, the drying of biotherapeutics is accomplished through freeze-drying, however, the removal of water by lyophilization possesses several drawbacks, including lengthy drying times, low energy efficiency, and the high cost of purchasing and maintaining the equipment. Furthermore, freezedr ying is a batch process which may be challenging to adapt and implement with the recent push for continuous manufacturing. These limitations have led to the search for next-generation drying technologies that can be applied to the manufacture of biotherapeutic products. Several alternative dr ying methods to freeze-dr ying have been developed and implemented in industries outside of pharmaceuticals, such as food and agriculture, and some are at an advanced state. With the aim of applying lessons learned from technologies in various industries, herein, we review several processing technologies with particular emphasis on the advantages and disadvantages of each in comparison to lyophilization and their potential to be adapted and utilized for drying biotherapeutic compounds.
Drying Technology, 2013
Biologic drug substances (DSs) are stored and transported as frozen bulk in various containers, each having disadvantages. We evaluated a powder-based bulk storage approach based on spray drying and demonstrate for the first time that monoclonal antibodies (mAbs) can be spray dried with >90% powder collection yield using a laboratory-scale spray dryer, which outperformed three benchtop units in yield and water content reduction. Cyclone design was critical to collection yield, which remained sensitive to sample formulations. High yield was achieved for three mAbs formulated at a 2:1 mAb: trehalose weight ratio. Increasing the amount of trehalose beyond this ratio decreased yield by increasing the amount of powder retained in the drying chamber, apparently due to increased particle tackiness. Despite a high inlet temperature, the physical stability of spray-dried mAbs was comparable to or greater than that of freeze-dried counterparts. Water content of the spray-dried powder was affected more by gas residence time in the dryer than by outlet and inlet temperatures. The laboratory-scale unit, which allowed longer gas residence time, produced drier powders even at high liquid feed rate. Characterization of spray-dried mAb reconstitution time and reconstituted solution turbidity demonstrated that the process was suitable for powder-based biologic DS bulk storage applications.
Stabilization of Proteins in Dry Powder Formulations Using Supercritical Fluid Technology
Pharmaceutical Research, 2004
chapter 2 18 ABSTRACT Therapeutic proteins have become essential in the treatment of many diseases. Their formulation in dry form is often required to improve their stability. Traditional freeze drying or spray drying processes are often harmful to labile proteins, and could be replaced by supercritical fluid (SCF) drying to produce particles with defined physicochemical characteristics in a mild single step. A survey of the current SCF drying processes for proteins is presented to give insight into the effect of SCF drying on protein stability and to identify issues that need further investigation. Methods used for drying aqueous and organic protein solutions are described. In particular, effects of process and formulation parameters on particle formation and protein stability are discussed. Although SCF methodology for drying proteins is still in its infancy, it can provide a serious alternative to existing drying methods for stabilizing proteins.
Aerosolization properties, surface composition and physical state of spray-dried protein powders
Journal of Controlled Release, 2004
Powder aerosols made of albumin, dipalmitoylphosphatidylcholine (DPPC) and a protein stabilizer (lactose, trehalose or mannitol) were prepared by spray-drying and analyzed for aerodynamic behavior, surface composition and physical state. The powders exited a Spinhalerk inhaler as particle aggregates, the size of which depending on composition, spray-drying parameters and airflow rate. However, due to low bulk powder tap density (b0.15 g/cm 3 ), the aerodynamic size of a large fraction of aggregates remained respirable (b5 Am). Fine particle fractions ranged between 21% and 41% in an Andersen cascade impactor operated at 28.3 l/min, with mannitol and lactose providing the most cohesive and free-flowing powders, respectively. Particle surface analysis by X-ray photoelectron spectroscopy (XPS) revealed a surface enrichment with DPPC relative to albumin for powders prepared under certain spray-drying conditions. DPPC self-organized in a gel phase in the particle and no sugar or mannitol crystals were detected by X-ray diffraction. Water sorption isotherms showed that albumin protected lactose from moisture-induced crystallization. In conclusion, a proper combination of composition and spray-drying parameters allowed to obtain dry powders with elevated fine particle fractions (FPFs) and a physical environment favorable to protein stability. D
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...
Processes
Nanoparticle-based therapeutics have been used in pulmonary formulations to enhance delivery of poorly water-soluble drugs, protect drugs against degradation and achieve modified release and drug targeting. This review focuses on the use of spray drying as a solidification technique to produce microparticles containing nanoparticles (i.e., nanoparticle (NP) agglomerates) with suitable properties as dry powders for inhalation. The review covers the general aspects of pulmonary drug delivery with emphasis on nanoparticle-based dry powders for inhalation and the principles of spray drying as a method for the conversion of nanosuspensions to microparticles. The production and therapeutic applications of the following types of NP agglomerates are presented: nanoporous microparticles, nanocrystalline agglomerates, lipid-based and polymeric formulations. The use of alternative spray-drying techniques, namely nano spray drying, and supercritical CO2-assisted spray drying is also discussed a...
European Journal of Pharmaceutical Sciences, 2018
Spray drying is increasingly becoming recognized as an efficient drying and formulation technique for pharmaceutical and biopharmaceutical processing. It offers significant economic and processing advantages compared to lyophilisation/freeze-drying techniques even though the optimisation of process parameters is often a costly and time-consuming procedure. Spray Drying has primarily been used in formulating small molecule drugs with low solubility however it is increasingly being applied to the processing of large biomolecules and biopharmaceuticals. This review examines the basics of spray drying process, current technology and various components used in spray drying process. Moreover, it is focused on introducing critical formulation and processing factors in spray drying of small molecule drugs and large biomolecules, their similarities and differences. Finally, it provides an overview of the experimental optimisation strategies designed to achieve optimum spray drying results in the shortest possible timeframe while utilising minimum product.
Perspective Chapter: Pharmaceutical Drying
IntechOpen eBooks, 2023
This chapter presents an overview of the perspective chapter on pharmaceutical drying within the context of drug manufacturing. It explores the significance of pharmaceutical drying in ensuring the stability and efficacy of drug products. The chapter begins by defining pharmaceutical drying and emphasizing its importance in the manufacturing process. Various methods of pharmaceutical drying, including air drying, vacuum drying, freeze-drying, and spray drying, are discussed, and a comparison between these methods is provided. Factors that influence pharmaceutical drying, such as physical and chemical properties of the product, drying temperature, drying time, pressure, humidity, and solvent properties, are examined. The chapter also highlights the challenges associated with pharmaceutical drying, including product stability and degradation, loss of potency, residual solvents, and the formation of amorphous or crystalline solids. Strategies to overcome these challenges, such as process optimization, the use of drying aids, control of drying parameters, and formulation considerations, are explored. Quality control measures in pharmaceutical drying, including the monitoring of residual moisture and solvent levels, characterization of dried products, and adherence to regulatory guidelines, are discussed.