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Biopharmaceutics

Problems may arise in the presence of hydrophobic active substances or excipients that are not wetted easily, fri these cases it may be necessary to add a disintegrating agent to the formulation. [Pg.53]

The choice of a diluent may influence the absorption of an active substance, which was seen in the l%Os in Australia. The diluent of phenytoin sodium capsules was changed from calcium sulfate dihydrate to lactose, which strongly enhanced the bioavailabdity of phenytoin sodium. Plasma levels of phenytoin increased up to fourfold, which led to an increased reporting of adverse events [8,9]. This case drew worldwide attention and resulted in an increased awareness of the importance of pharmaceutical availability and bioavailability of active substances in the development of solid oral dosage forms. [Pg.53]

Capsules release their contents when at least a part of the capsule shell is dissolved. The Ph. Eur. requires that capsules disintegrate within 30 min [6]. However, the shell of gelatine capsules usually dissolves within 3-15 min in the aqueous, acidic gastric lumen. The powder in capsules prepared in the pharmacy has not been subjected to a compression stage, as is the case of most industrially manufactored capsules. Therefore, the content of pharmacy prepared capsules is usually released more quickly than industrial prepared capsules. [Pg.53]

In addition to the disintegration of a capsule or tablet, absorption rate is determined by the dissolution rate of the active substance. The dissolution rate of the active substance depends on various factors, for example the solubility, the particle size and shape, the crystal morphology, and wetting ability. Section 18.1 discusses the effects of these factors on the absorption of the active substance. [Pg.53]

Ingestion of a tablet should not always lead to a rapid release. In a number of cases it may be preferred that the active substance is not released directly, for example [10]  [Pg.53]


The three main sources of competitive advantage in the manufacture of high value protein products are first to market, high product quaUty, and low cost (3). The first company to market a new protein biopharmaceutical, and the first to gain patent protection, enjoys a substantial advantage. The second company to enter the market may find itself enjoying only one-tenth of the sales. In the absence of patent protection, product differentiation becomes very important. Differentiation reflects a product that is purer, more active, or has a greater lot-to-lot consistency. [Pg.42]

Table 1. Unit Values and Relative Production Quantities for Selected Approved Biopharmaceuticals, 1990—199T... Table 1. Unit Values and Relative Production Quantities for Selected Approved Biopharmaceuticals, 1990—199T...
An overview of the general principles of filtration having specific appHcation to bacterial and viral removal is given herein. The emphasis is on ensuring that the sterility and/or safety of biologicals and biopharmaceuticals be maintained. [Pg.139]

Human blood plasma contains over 700 different proteins (qv) (1). Some of these are used in the treatment of illness and injury and form a set of pharmaceutical products that have become essential to modem medicine (Table 1). Preparation of these products is commonly referred to as blood plasma fractionation, an activity often regarded as a branch of medical technology, but which is actually a process industry engaged in the manufacture of speciaUst biopharmaceutical products derived from a natural biological feedstock (see Pharmaceuticals). [Pg.526]

L. Shargeland A. B. C. Yu, Applied Biopharmaceutics and Pharmacokinetics, 2nd ed., Appleton-Centaiy Ctofts,No-rwalk, Conn., 1985. [Pg.283]

Membrane-retained components are collectively called concentrate or retentate. Materials permeating the membrane are called filtrate, ultrafiltrate, or permeate. It is the objective of ultrafiltration to recover or concentrate particular species in the retentate (eg, latex concentration, pigment recovery, protein recovery from cheese and casein wheys, and concentration of proteins for biopharmaceuticals) or to produce a purified permeate (eg, sewage treatment, production of sterile water or antibiotics, etc). Diafiltration is a specific ultrafiltration process in which the retentate is further purified or the permeable sohds are extracted further by the addition of water or, in the case of proteins, buffer to the retentate. [Pg.293]

U. Gundert-Remy and H. Mufler, eds.. Oral Controlled Release Products Therapeutic and Biopharmaceutic Assessment, Wissenschafdiche VedagsgeseUschaft mbH, Stuttgart, Germany, 1990. [Pg.151]

Four column systems are available from Amersham Pharmacia Biotech that can be used to pack SEC media for various applications at the laboratory scale. These include C, XK, SR, and HR column systems. All of the laboratory-scale columns are constructed with borosilicate glass tubes. Columns for larger scale process applications include INdEX, BPG, EineLINE, BPSS, and Stack columns. The larger scale columns are constructed to meet stringent validation requirements for the production of biopharmaceuticals. Each of the column types are described. [Pg.54]

The EineLINE series of columns was designed to meet the stringent demands of hygiene required in the production of biopharmaceuticals. These stainless-steel-based columns employ a hydraulic flow adaptor and may be operated at... [Pg.58]

BioProcess stainless-steel columns are fixed bed height columns designed for the most stringent requirements in the routine production of biopharmaceuticals. Wetted materials include stainless steel, polypropylene, and EPDM. The BPSS series may be operated at pressures up to 3 bar (0.3 MPa) and are supplied with sanitary fittings of 10 or 22 mm i.d. The available column sizes and specifications for the BPSS column series are given in Table 2.18. [Pg.59]

APPLICATION OF SIZE EXCLUSION-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY FOR BIOPHARMACEUTICAL PROTEIN AND PEPTIDE THERAPEUTICS... [Pg.531]

Biopharmaceutical Product Development, Eli Lilly and Company, Indianapolis, Indiana 4618S... [Pg.531]

Niazi, S. Textbook of Biopharmaceutics and Clinical Pharmacokinetics Appleton-Century-Crofts New York, 1979 p 158. [Pg.128]

In-vitro models can provide preliminary insights into some pharmacodynamic aspects. For example, cultured Caco 2 cell lines (derived from a human colorectal carcinoma) may be used to simulate intestinal absorption behaviour, while cultured hepatic cell lines are available for metabolic studies. However, a comprehensive understanding of the pharmacokinetic effects vfill require the use of in-vivo animal studies, where the drug levels in various tissues can be measured after different dosages and time intervals. Radioactively labelled drugs (carbon-14) may be used to facilitate detection. Animal model studies of human biopharmaceutical products may be compromised by immune responses that would not be expected when actually treating human subjects. [Pg.64]

Product Development Rationale Overview of Biopharmaceutics Overview of Clinical Pharmacology Overview of Efficacy Overview of Safety Benefits and Risks Conclusions Literature References... [Pg.109]

Summary of Biopharmaceutic Studies and Associated Analytical Methods Summary of Clinical Pharmacology Studies Summary of Clinical Efficacy Summary of Clinical Safety Literature References Synopses of Individual Studies... [Pg.109]

Biomimetic polymers in pharmaceutical and biomedical sciences. Eitropean Journal of Pharmaceutics and Biopharmaceutics, Vol. 58, 2, (September 2004), pp. (385-407), ISSN 0939-6411... [Pg.80]


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Absorption biopharmaceutics classification system

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Affinity-based biopharmaceutical

Alternative Strategies and New Cell Lines for High-level Production of Biopharmaceuticals

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Biopharmaceutic classification system

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Biopharmaceutical

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Biopharmaceutical Classification System application

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Biopharmaceutical Conjugates

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Biopharmaceutical Players Will Need to Adapt their Portfolios and Business Models

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Biopharmaceutical Separations by Ultrafiltration

Biopharmaceutical application

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Biopharmaceutical assessment

Biopharmaceutical classification

Biopharmaceutical classification compounds

Biopharmaceutical classification system (BCS

Biopharmaceutical companies

Biopharmaceutical considerations

Biopharmaceutical current status

Biopharmaceutical discovery phase

Biopharmaceutical drug

Biopharmaceutical drug characterization

Biopharmaceutical drug classification

Biopharmaceutical drug classification systems

Biopharmaceutical drug design

Biopharmaceutical drug preformulation studies

Biopharmaceutical drug tests

Biopharmaceutical equivalence

Biopharmaceutical future prospects

Biopharmaceutical importance of particle size

Biopharmaceutical industry

Biopharmaceutical industry protein-based therapeutics

Biopharmaceutical laboratory

Biopharmaceutical materials

Biopharmaceutical permeability

Biopharmaceutical products, aggregation

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Biopharmaceutical properties overview

Biopharmaceutical proteins

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Biopharmaceutical regulatory aspect

Biopharmaceutical research

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Biopharmaceutical substrate

Biopharmaceutical therapeutic agents

Biopharmaceutical therapies

Biopharmaceuticals

Biopharmaceuticals

Biopharmaceuticals Characterization

Biopharmaceuticals Classification

Biopharmaceuticals Classification System

Biopharmaceuticals Definition and Regulation

Biopharmaceuticals Derived from Transgenic Plants and Animals

Biopharmaceuticals Market

Biopharmaceuticals Stability

Biopharmaceuticals activity

Biopharmaceuticals advantages

Biopharmaceuticals and pharmaceutical biotechnology

Biopharmaceuticals antibody-based

Biopharmaceuticals approval requirements

Biopharmaceuticals approved products

Biopharmaceuticals bioavailability

Biopharmaceuticals bioequivalence

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Biopharmaceuticals carcinogenicity testing

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Biopharmaceuticals chloroplasts

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Biopharmaceuticals defined

Biopharmaceuticals definitions

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Biopharmaceuticals developing

Biopharmaceuticals development

Biopharmaceuticals disintegration

Biopharmaceuticals dissolution

Biopharmaceuticals dose-response

Biopharmaceuticals enzyme-based

Biopharmaceuticals expressing

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Biopharmaceuticals features

Biopharmaceuticals food, effect

Biopharmaceuticals formulation factors, dissolution

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Biopharmaceuticals genotoxicity

Biopharmaceuticals genotoxicity testing

Biopharmaceuticals glycosylation, therapeutic proteins

Biopharmaceuticals guidelines

Biopharmaceuticals immune response

Biopharmaceuticals immunotoxicity testing

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Biopharmaceuticals molecular structure

Biopharmaceuticals oral drug absorption

Biopharmaceuticals overview

Biopharmaceuticals particle size

Biopharmaceuticals permeability class

Biopharmaceuticals plant-derived protein

Biopharmaceuticals plants expressing

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Biopharmaceuticals reproductive/developmental toxicity

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Biopharmaceuticals thus far approved in the USA or European Union

Biopharmaceuticals tissue cross-reactivity testing

Biopharmaceuticals tissue distribution

Biopharmaceuticals toxicity studies

Biopharmaceuticals vaccine, transgenic plants

Biopharmaceuticals viral expression vectors

Biopharmaceuticals, safety assessment

Biopharmaceuticals, safety assessment species selection

Biopharmaceuticals/biologics

Biopharmaceuticals/biologics definition

Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition by Gary Walsh

Biopharmaceutics Building

Biopharmaceutics Classification

Biopharmaceutics Classification Scheme

Biopharmaceutics Classification System

Biopharmaceutics Classification System Redefining BSC Solubility Class Boundary

Biopharmaceutics Classification System characterization

Biopharmaceutics Classification System frameworks

Biopharmaceutics Classification System permeability measurements

Biopharmaceutics Classification System prediction

Biopharmaceutics Classification of Drugs

Biopharmaceutics Drug Disposition

Biopharmaceutics Drug Disposition Classification System

Biopharmaceutics System

Biopharmaceutics and Relevant

Biopharmaceutics and pharmacokinetics

Biopharmaceutics basics

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Biopharmaceutics containers

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Biopharmaceutics oral absorption

Biopharmaceutics parenteral

Biopharmaceutics preparation method

Biopharmaceutics pulmonary

Biopharmaceutics rectal

Biopharmaceutics studies

Biopharmaceutics studies animal models

Biopharmaceutics studies bioavailability

Biopharmaceutics vaginal

Biopharmaceutics, defined

C6 Cells for the Manufacture of Biopharmaceutical Proteins

Candidate drug selection biopharmaceutical support

Capsules biopharmaceutics

Carcinogenicity studies biopharmaceuticals

Cell culture technology biopharmaceutical production

Chemical Modification of Peptide and Protein Biopharmaceuticals

Chloroplast-derived Biopharmaceuticals

Chromatographic separation biopharmaceutical

Classes of Biopharmaceuticals

Commercial Biopharmaceuticals with Human Clinical Experience for Therapeutic, Immunoprophylactic, and Medical Device Use derived from Transgenic Systems

Comparability studies biopharmaceuticals

Comparison of Cell Culture over Whole Plants for Biopharmaceutical Production

Considerations for Developing Biopharmaceuticals FDA Perspective

Contract Manufacturing of Biopharmaceuticals Including Antibodies or Antibody Fragments

Covalent structures biopharmaceutical

Delivery of biopharmaceuticals

Design of Modern Biopharmaceuticals by Ultra-high-throughput Screening and Directed Evolution

Development of Biopharmaceuticals itius, Altius, Fortius - Acceleration by High Throughput and Ultra-HT

Directed Evolution of Biopharmaceuticals

Dispersing biopharmaceutics

Double-stranded Decoy Oligonucleotides as new Biopharmaceuticals

Downstream Processing of Plant-Derived Biopharmaceuticals

Downstream processing, biopharmaceuticals

Drug development biopharmaceutical technologies

Drug substances biopharmaceutical classification

Drug substances biopharmaceutical properties

Drug targets biopharmaceutical therapies

Emulsions biopharmaceutics

Engineered biopharmaceuticals

Engineered biopharmaceuticals insulins

Engineering and Production of Biopharmaceuticals

Estimation of Biopharmaceutical Properties

European Union biopharmaceuticals

ExpressTec High-level Expression of Biopharmaceuticals in Cereal Grains

Expression systems, biopharmaceutical production

Fermentation biopharmaceutical from

Formulation biopharmaceutical classification

Formulation development biopharmaceutics

Functional bioassays biopharmaceutical

Generic biopharmaceuticals

Genotoxicity studies biopharmaceuticals

Genotoxicity, biopharmaceutical testing

Glycosylated protein biopharmaceuticals

Glycosylated protein biopharmaceuticals studies

Glycosylation biopharmaceutical

Healthcare Trends and their Impact on the Biopharmaceutical Industry Biopharmaceuticals Come of Age

Higher-Order Structure and HX-MS in the Biopharmaceutical Industry

Host-cell proteins biopharmaceutical

Human protein biopharmaceuticals

Humanized Glycosylation Production of Biopharmaceuticals in a Moss Bioreactor

Immunomodulatory biopharmaceuticals

Immunomodulatory biopharmaceuticals models

Immunotoxicity studies biopharmaceuticals

Impact of Plant-Made Biopharmaceuticals on Human Health

Impact of Plant-Made Biopharmaceuticals on the Environment

Industries, commercialization biopharmaceuticals

Inhalation biopharmaceutics

Interferons approved biopharmaceuticals

Introduction to Biopharmaceuticals

Japan biopharmaceuticals

Key Biopharmaceutical Journals

Large Molecule Biopharmaceutical Drugs

MODELING IN BIOPHARMACEUTICS

Manufacture of Recombinant Biopharmaceutical Proteins by Cultivated Mammalian ells in Bioreactors

Manufacturing Recombinant Protein Biopharmaceuticals

Marketed biopharmaceuticals, improving

Marketing requirements, biopharmaceuticals

Molecular mass biopharmaceuticals

Monoclonal antibodies approved biopharmaceuticals

Monoclonal antibodies biopharmaceutical evaluation

Nonprotein-coding RNAs and their Potential as Biopharmaceuticals

Oral dosage form Biopharmaceutics Classification System

Oral solids biopharmaceutics

Oxidation biopharmaceutical proteins

Parenteral preparations biopharmaceutics

Permeability biopharmaceutics classification system

Pharmacokinetics biopharmaceuticals

Physicochemical and biopharmaceutical properties

Plant Viral Expression Vectors and Production of Biopharmaceuticals in Plants

Plant-derived biopharmaceutical

Poly(ethylene) Glycol Conjugates of Biopharmaceuticals in Drug Delivery

Posttranslational biopharmaceutical

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating

Primary structure biopharmaceutical

Process-related impurities biopharmaceutical

Producing Recombinant Protein Biopharmaceuticals

Product design biopharmaceutic considerations

Product-related impurities biopharmaceutical

Production of Biopharmaceuticals The Industrys Workhorses - Mammalian Expression Systems

Production of Biopharmaceuticals in Plant Suspension Cells

Protein biopharmaceuticals

Protein biopharmaceuticals approaches

Protein biopharmaceuticals challenges

Protein biopharmaceuticals comparability studies

Protein biopharmaceuticals example

Protein biopharmaceuticals posttranslational modification

Quantitative biopharmaceutics classification system

Regulation of Plant-Made Biopharmaceuticals

Regulatory guidelines biopharmaceuticals

Repeat-dose toxicity studies biopharmaceuticals

Reproductive/developmental toxicity studies biopharmaceuticals

Risk Analysis and Safety of Plant-Made Biopharmaceuticals

Saccharomyces cerevisiae, biopharmaceuticals

Safety assessment biopharmaceutical products

Safety pharmacology biopharmaceuticals

Silicone Oil in Biopharmaceutical Containers Applications and Recent Concerns

Single-dose toxicity study biopharmaceuticals

Small molecule biopharmaceutical

Solubility biopharmaceutics classification system

Sources of biopharmaceuticals

Suspension cells, production biopharmaceuticals

Szymanski, Jan Barciszewski and Volker A. Erdmann 9 Double-stranded Decoy Oligonucleotides as new Biopharmaceuticals

Tablets biopharmaceutics

Target Safety Assessment for Biopharmaceuticals Targeting the Immune System

The Biopharmaceutics Classification System

The Biopharmaceutics Classification System (BCS)

The Biopharmaceutics Drug Classification Systems

The First Biopharmaceutical from Transgenic Animals ATryn

The Role of HX-MS in Biopharmaceutical Comparability Studies

The Use of Alveolar Epithelial Cells in Biopharmaceutical Research

The age of biopharmaceuticals

Therapeutic categories biopharmaceuticals

Upstream processing, biopharmaceuticals

Use of Nonactive Pharmaceutical Excipients in Oral Drug Formulations Biopharmaceutical Classification System Considerations

Use of Size Exclusion Chromatography in Biopharmaceutical Development

Vaccines approved biopharmaceuticals

Veterinary biopharmaceuticals

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

Water for biopharmaceutical processing

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