Drug Delivery Aspects of Biotechnology Products

Burgess, Diane J.

doi:10.1007/978-94-015-8135-6_6

Cited by 6 publications

(6 citation statements)

References 92 publications

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“…Several groups have reported that modification of GlyA1 causes diminished receptor binding and a loss of biological activity. 7 Conversely, (MPEG) modification of PheB1 reduces the antigenicity of the protein, and PheB1 modification with glucosyl-PEG has been reported to suppress the association of insulin monomers/dimers into hexamers. 80,81 Likewise, modification of either PheB1 or LysB29 has been shown to improve the pharmaceutical performance (e.g., increased plasma half-life, reduced immunogenicity and antigenicity, improved resistance to proteolysis, increased aqueous/ organic solubilities) of the insulin conjugates thus produced while not significantly compromising receptor binding or biological activity.…”

Section: Improving the Oral Activity Of Calcitonin And Insulin Througmentioning

confidence: 98%

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Oral Protein and Peptide Drug Delivery

Soltero¹

2005

Drug Delivery

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Section: Improving the Oral Activity Of Calcitonin And Insulin Througmentioning

confidence: 98%

“…1 Among the alternate routes that have been tried with varying degrees of success are the oral, buccal, 2 intranasal, 3 pulmonary, 4 transdermal, 5 ocular, 6 and rectal 7 approaches. The many benefits of oral administration of therapeutic agents make oral polypeptide delivery stand out from among these drug delivery alternatives.…”

Section: Introductionmentioning

confidence: 99%

Oral Protein and Peptide Drug Delivery

Soltero¹

2005

Drug Delivery

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“…Several new protein delivery methods are being developed primarily to address market competition for approved protein therapeutics such as insulin, human growth hormone, interferons and erythropoetin. These systems seek to provide an advantage by improving patient convenience and/or regulatory compliance (Burgess, 1993).…”

Section: Drug Delivery and Particie Formationmentioning

confidence: 99%

“…Therefore, dénaturation rarely occurs in small peptides, which do not possess high levels of structural order. Both physical and chemical changes in peptides and proteins can result in a loss of biological activity (Banga, 1995, Burgess, 1993, Golker, 1991, Krijgsman, 1992a, Wong et al, 1997.…”

Section: Effect O F Operating Conditions On Bioiogicai Functionalitymentioning

confidence: 99%

Investigation of Supercritical Fluid Technology to Produce Dry Particulate Formulations of Antibody Fragments

Sarup

Servistas

Sloan

et al. 2000

Food and Bioproducts Processing

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Investigation of Supercritical Fluid Technology to Produce Dry Particulate Formulations of Antibody Fragments Micro, submicrometre and ultrafine particles are increasingly in demand as they have a broad application in pharmaceutical delivery and needle-free powder injection. Conventional methods of powder preparation including freeze-drying and spray drying have considerable disadvantages for these applications.The use of supercritical fluids for materials' processing is one of the efficient and novel approaches used to achieve high purity micron-sized particles in a single step. The technique of Solution Enhanced Dispersion by Supercritical Fluids (SEDS) dramatically reduces or eliminates the problems associated with current, conventional particle-formation and size-reduction processes. SEDS involves the rapid dispersion, mixing and extraction of a protein solution, anti-solvent and supercritical carbon dioxide. SEDS has been used to produce dry particulate formulations of three antibody fragments (D1.3Fv, 4D5Fab, PEG-4D5Fab) and a whole antibody (CDP850). The aim of this research was to assess affects of the SEDS process on the functionality antibody fragments and antibody.The results demonstrated that dried formulations of antibody fragments and antibody can be produced using the SEDS process. The level of damage caused during SEDS was found to be dependent on choice solvent and protein. The main cause of activity loss was identified as the presence of both water and solvent during SEDS processing. 3 Dedication 4 Table of Contents 5List of Figures 9 List of Tabies 10Chapter One -Introduction proteins the limitations are obvious. Spray drying can induce dénaturation and a low product yield. Milling, which can result in activated surface particles and produce a broad size distribution and fluid energy grinding, which frequently results in electrostatically charged powders, are more efficient for hard and brittle materials than for soft substances like proteins (Moshashaée et al., 2000, Palakodaty et al., 2000.One method of size reduction and particle formation capable of yielding very small particles and a narrow size distribution and devoid of certain drawbacks of conventional techniques, is one that utilises supercritical carbon dioxide. Supercritical fluid technology, and especially the solution enhanced dispersion by supercritical fluids (SEDS) process, has shown great promise in applications such as preparing particulate pharmaceuticals with defined physiochemical properties (Palakodaty etal., 2000).

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“…Patient compliance with drug administration regimens by any of these parenteral routes is generally poor and severely restricts the therapeutic value of the drug, particularly for disease such as diabetes 1 . Among the alternate routes that have been tried with varying degrees of success are the oral, buccal 4 , intranasal 5 , pulmonary 6 , transdermal 7 , ocular 8 and rectal 9 . Among these, oral route remains the most convenient way of delivering drugs.…”

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confidence: 99%

Protein and peptide drug delivery: Oral approaches

Shaji¹,

Patole²

2008

Indian J Pharm Sci

216

118

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Till recent, injections remained the most common means for administering therapeutic proteins and peptides because of their poor oral bioavailability. However, oral route would be preferred to any other route because of its high levels of patient acceptance and long term compliance, which increases the therapeutic value of the drug. Designing and formulating a polypeptide drug delivery through the gastro intestinal tract has been a persistent challenge because of their unfavorable physicochemical properties, which includes enzymatic degradation, poor membrane permeability and large molecular size. The main challenge is to improve the oral bioavailability from less than 1% to at least 30-50%. Consequently, efforts have intensified over the past few decades, where every oral dosage form used for the conventional small molecule drugs has been used to explore oral protein and peptide delivery. Various strategies currently under investigation include chemical modification, formulation vehicles and use of enzyme inhibitors, absorption enhancers and mucoadhesive polymers. This review summarizes different pharmaceutical approaches which overcome various physiological barriers that help to improve oral bioavailability that ultimately achieve formulation goals for oral delivery.

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Drug Delivery Aspects of Biotechnology Products

Cited by 6 publications

References 92 publications

Oral Protein and Peptide Drug Delivery

Oral Protein and Peptide Drug Delivery

Investigation of Supercritical Fluid Technology to Produce Dry Particulate Formulations of Antibody Fragments

Protein and peptide drug delivery: Oral approaches

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