Innovative Drying Technologies for Biopharmaceuticals

Sharma, Ashutosh; Khamar, Dikshitkumar; Cullen, Sean P.; Hayden, Ambrose; Hughes, Helen

doi:10.1016/j.ijpharm.2021.121115

Cited by 56 publications

(21 citation statements)

References 244 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Some papers highlight that sudden changes in temperature cause inhibition of the plant enzymatic activity of cytochrome P450, responsible for the synthesis of LD. Additionally, LD instability under strong thermal processes was largely demonstrated (e.g., freeze-drying, freezing, cooking, and high-temperature heating) [ 11 , 23 , 31 , 48 ].…”

Section: Resultsmentioning

confidence: 99%

Development and Validation of a Reversed-Phase HPLC Method with UV Detection for the Determination of L-Dopa in Vicia faba L. Broad Beans

et al. 2022

View full text Add to dashboard Cite

L-Dopa (LD), a substance used medically in the treatment of Parkinson’s disease, is found in several natural products, such as Vicia faba L., also known as broad beans. Due to its low chemical stability, LD analysis in plant matrices requires an appropriate optimization of the chosen analytical method to obtain reliable results. This work proposes an HPLC-UV method, validated according to EURACHEM guidelines as regards linearity, limits of detection and quantification, precision, accuracy, and matrix effect. The LD extraction was studied by evaluating its aqueous stability over 3 months. The best chromatographic conditions were found by systematically testing several C18 stationary phases and acidic mobile phases. In addition, the assessment of the best storage treatment of Vicia faba L. broad beans able to preserve a high LD content was performed. The best LD determination conditions include sun-drying storage, extraction in HCl 0.1 M, chromatographic separation with a Discovery C18 column, 250 × 4.6 mm, 5 µm particle size, and 99% formic acid 0.2% v/v and 1% methanol as the mobile phase. The optimized method proposed here overcomes the problems linked to LD stability and separation, thus contributing to the improvement of its analytical determination.

show abstract

Section: Resultsmentioning

confidence: 99%

Development and Validation of a Reversed-Phase HPLC Method with UV Detection for the Determination of L-Dopa in Vicia faba L. Broad Beans

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Other methods, namely vacuum drying, microwave drying, and electrospinning are drawing attention as they show potential for being more efficient drying methods than conventional ones (Sharma et al 2021 ).…”

Section: Drying Techniquesmentioning

confidence: 99%

“…In recent decades, biopharmaceuticals, including peptides, proteins, vaccines, genes, hormones, and enzymes (Sharma et al 2021 ; O’Sullivan et al 2022a , b ) have experienced rapid growth in their production (Chen et al 2021a , b ). Biopharmaceutical drugs have accounted for 35% of all FDA-approved products over the past 16 years (Vass et al 2019 ), and it is projected that by 2025, this market will be worth $395 billion (Guo et al 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals

Emami

Shokooh

Yazdi

2022

J. Pharm. Investig.

View full text Add to dashboard Cite

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.

show abstract

“…In contrast, spray drying is an enabling particle engineering technique, used to manufacture respirable particles of both small and large molecule active pharmaceutical ingredients (API) in a single-unit operation [7][8][9]. Spray drying as a pharmaceutical manufacturing technique has been reviewed extensively elsewhere [10,11].…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Spray Drying for Combination Dry Powder Inhaler Formulations

2022

View full text Add to dashboard Cite

Spray drying is a particle engineering technique used to manufacture respirable pharmaceutical powders that are suitable for delivery to the deep lung. It is amenable to processing both small molecules and biologic actives, including proteins. In this work, a simultaneous spray-drying process, termed simul-spray, is described; the process involves two different active pharmaceutical ingredient (API) solutions that are simultaneously atomized through separate nozzles into a single-spray dryer. Collected by a single cyclone, simul-spray produces a uniform mixture of two different active particles in a single-unit operation. While combination therapies for dry powder inhalers containing milled small molecule API are commercially approved, limited options exist for preparing combination treatments that contain both small molecule APIs and biotherapeutic molecules. Simul-spray drying is also ideal for actives which cannot withstand a milling-based particle engineering process, or which require a high dose that is incompatible with a carrier-based formulation. Three combination case studies are demonstrated here, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation. These model systems were chosen for their potential relevance to the local treatment of lung cancer. The resulting formulations preserved the biologic activity of the antibody, achieved target drug concentration, and had aerosol properties suitable for pulmonary delivery.

show abstract

Innovative Drying Technologies for Biopharmaceuticals

Cited by 56 publications

References 244 publications

Development and Validation of a Reversed-Phase HPLC Method with UV Detection for the Determination of L-Dopa in Vicia faba L. Broad Beans

Development and Validation of a Reversed-Phase HPLC Method with UV Detection for the Determination of L-Dopa in Vicia faba L. Broad Beans

Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals

Simultaneous Spray Drying for Combination Dry Powder Inhaler Formulations

Contact Info

Product

Resources

About