Abstract
It is well known that protein/peptide-based drug formulations are more stable in the solid state than in the liquid state, thereby offering stability advantages in ambient temperature storage, product shipping/distribution, and long-term shelf life. Novel powder-based drug delivery systems recently emerging for applications in sustained release, inhalation, intradermal delivery, etc. add more value to protein solid dosage forms. Despite great research interests in understanding the drying effects on protein stability and a large collection of publications focusing on this area, systematic accounts of powder formation techniques are lacking. This review is to summarize a number of methods currently available for protein powder preparation. Some are common methods such as lyophilization, spray drying, pulverization, and precipitation, and some methods are more recently developed such as supercritical fluid precipitation, spray-freeze drying, fluidized-bed spray coating and emulsion precipitation. In ad dition to examining the individual process effect on protein stability that is always the focus of formulation scientists, this review also likes to evaluate each method from a more practical sense in terms of process versatility and scalability. The conclusion is that each method has its own advantages and the use of a method is formulation and application specific. With the understanding of the principles and advantages of these methods, it can benefit our choice on selecting appropriate techniques for preparing a desired protein powder formulation for specific applications
Keywords: Protein based drug formulation, Peptide based drug formulation, Spray drying, Protein stability, Particle shape, Particle morphology
Current Pharmaceutical Biotechnology
Title: Biopharmaceutical Powders Particle Formation and Formulation Considerations
Volume: 1 Issue: 3
Author(s): Yuh-Fun Maa and Steven J. Prestrelski
Affiliation:
Keywords: Protein based drug formulation, Peptide based drug formulation, Spray drying, Protein stability, Particle shape, Particle morphology
Abstract: It is well known that protein/peptide-based drug formulations are more stable in the solid state than in the liquid state, thereby offering stability advantages in ambient temperature storage, product shipping/distribution, and long-term shelf life. Novel powder-based drug delivery systems recently emerging for applications in sustained release, inhalation, intradermal delivery, etc. add more value to protein solid dosage forms. Despite great research interests in understanding the drying effects on protein stability and a large collection of publications focusing on this area, systematic accounts of powder formation techniques are lacking. This review is to summarize a number of methods currently available for protein powder preparation. Some are common methods such as lyophilization, spray drying, pulverization, and precipitation, and some methods are more recently developed such as supercritical fluid precipitation, spray-freeze drying, fluidized-bed spray coating and emulsion precipitation. In ad dition to examining the individual process effect on protein stability that is always the focus of formulation scientists, this review also likes to evaluate each method from a more practical sense in terms of process versatility and scalability. The conclusion is that each method has its own advantages and the use of a method is formulation and application specific. With the understanding of the principles and advantages of these methods, it can benefit our choice on selecting appropriate techniques for preparing a desired protein powder formulation for specific applications
Export Options
About this article
Cite this article as:
Maa Yuh-Fun and Prestrelski J. Steven, Biopharmaceutical Powders Particle Formation and Formulation Considerations, Current Pharmaceutical Biotechnology 2000; 1 (3) . https://dx.doi.org/10.2174/1389201003378898
DOI https://dx.doi.org/10.2174/1389201003378898 |
Print ISSN 1389-2010 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4316 |
Call for Papers in Thematic Issues
Artificial Intelligence in Bioinformatics
Bioinformatics is an interdisciplinary field that analyzes and explores biological data. This field combines biology and information system. Artificial Intelligence (AI) has attracted great attention as it tries to replicate human intelligence. It has become common technology for analyzing and solving complex data and problems and encompasses sub-fields of machine ...read more
Latest Advancements in Biotherapeutics
The scope of this thematic issue is to comprehensively explore the rapidly evolving landscape of biotherapeutics, emphasizing breakthroughs in precision medicine. Encompassing diverse therapeutic modalities, the issue will delve into the latest developments in monoclonal antibodies, CRISPR/Cas gene editing, CAR-T cell therapies, and innovative drug delivery systems, such as nanoparticle-based ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Modern drug delivery systems for targeting the posterior segment of the eye
Current Pharmaceutical Design How Should We Treat Hypertension and Dyslipidemia in Patients with Prediabetes?
Current Pharmaceutical Design Drug Delivery Systems from Nose to Brain
Current Pharmaceutical Biotechnology Nafion/Multi-wall Carbon Nanotubes Composite Modified Glassy Carbon Electrode for Sensitive Determination of Bilirubin
Current Nanoscience Potential Therapeutic Properties of Natural Products Through the Expression of Heme Oxygenase-1
Mini-Reviews in Organic Chemistry Prospecting for New Inhibitors of Anaplastic Lymphoma Kinase, A Clinically Relevant Oncogenic Drug Target
Current Bioactive Compounds Effects of Ranolazine on Cardiovascular System
Recent Patents on Cardiovascular Drug Discovery Natural Aldose Reductase Inhibitor: A Potential Therapeutic Agent for Non-alcoholic Fatty Liver Disease
Current Drug Targets Editorial Statins: [Hot Topic: Statins: Effects Beyond Cholesterol Lowering (Guest Editor: Garry X. Shen)]
Current Drug Targets - Cardiovascular & Hematological Disorders Risperidone Rechallenge for Marked Liver Function Test Abnormalities in an Autistic Child
Recent Patents on Endocrine, Metabolic & Immune Drug Discovery Selenoproteins and their Role in Oxidative Stress and Inflammation
Current Chemical Biology PET Studies with Carbon-11 Radioligands in Neuropsychopharmacological Drug Development
Current Pharmaceutical Design Regulation of Myometrial Smooth Muscle Functions
Current Pharmaceutical Design Functional Neuroimaging in Memory and Memory Disturbances
Current Medical Imaging Is Erectile Dysfunction an Example of Abnormal Endothelial Function?
Current Vascular Pharmacology Heart Disease Prediction System Using Decision Tree and Naive Bayes Algorithm
Current Medical Imaging Acute Effects of Oral Tofisopam on Plasma Concentration and Urinary Excretion of Uric Acid and Oxypurinol “Preliminary Communication”
Current Clinical Pharmacology Effects of Mulberry on The Central Nervous System: A Literature Review
Current Neuropharmacology Empagliflozin and the Diabetic Kidney: Pathophysiological Concepts and Future Challenges
Endocrine, Metabolic & Immune Disorders - Drug Targets Cystic Fibrosis and the Innate Immune System: Therapeutic Implications
Endocrine, Metabolic & Immune Disorders - Drug Targets