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Concern over preservatives
update
news
PSTT Vol. 1, No. 3 June 1998
Concern over preservatives David Bradley, tel/fax: ⫹44 1954 202218, Web: http://www.camsoft.com/elemental/
Asthma experts have called for a ban on the use of preservatives such as the commonly used benzalkonium chloride and the stabilizer ethylenediamine tetra acetate (EDTA), in medications because of links with increased airway obstruction in sufferers of asthma and chronic pulmonary disease. A review of studies on the use of medications with and without preservatives, could not find any real benefit from their use in terms of reducing bacterial contamination. The researchers in these studies, including Leslie Hendeles (University of Florida College of Medicine, Gainesville, FL, USA), recently discussed the safety implications of these additives in nebulizer solutions, used to treat lung dysfunction, and believe that, rather than
benefiting the patient and preventing infection, they pose a substantial risk by constricting airways and reducing the effectiveness of the medication1. Nebulizer solutions are used in the treatment of asthma, emphysema and chronic bronchitis. Researchers have found that the amount of benzalkonium chloride contained in a standard prescription vial actually leads to constriction of the airways, counteracting the effects of the medication and sometimes worsening lung function in the patient; similar effects were reported for EDTA when higher doses of the stabilizer were inhaled. According to Hendeles, safer, preservative-free medications are available in sterile, single-dose vials and pharmacists, at
least in the USA, tend not to consider the presence of preservatives in a vial and (legally) dispense preservative-containing and preservativefree products as if they were equivalent – often regardless of the specification of the prescribing doctor. Alerted to the problem, the Florida State Board of Pharmacy has drawn attention to the issue in a newsletter, that was sent to pharmacists throughout the state. The more common metered-dose inhalers, which release salbutamol and/or corticosteroids, do not include the preservatives and so, according to the scientists, users are not at risk.
Reference 01
Beasley, R. (1998) Pharmacotherapy 18, 130–139
Book review Biopharmaceuticals: Biochemistry and Biotechnology by Gary Walsh, John Wiley & Sons, 1998. £29.95 (xvi⫹431 pages) ISBN: 0 4719 7789 6
The stated aim of the book is to provide an overview of the science and applications of biopharmaceutical products. A tall order for any single volume. It is targeted at undergraduate and postgraduate students or employees in the industry seeking to gain a wider perspective of the field. Inevitably, given the scope and target markets, there are areas of lightweight coverage and omission. However, the rationale for selective coverage of topics is not always clear; perhaps this represents the coverage of a related coursework programme. For example, Chapter 3 detailing manufacturing processes spans some 80 pages; biopharmaceutical products present a complex set of problems for manufacture, and it is understandable that this section should be extensive. The sec-
94
tion detailing modern approaches to development of pharmaceuticals extends to just under 40 pages and this section incorporates scant coverage of new drug discovery. This itself should have warranted a separate section, given the recent and on-going revolution in advanced technologies such as combinatorial chemistry, high-throughput screening and genomics. The sections focusing on therapeutic agents themselves include extensive coverage of cytokines, growth factors, hormones, blood products and therapeutic enzymes, and antibodies, vaccines and adjuvants. The book focuses on peptide-based therapies, and the major topics of nucleic acid therapeutics, antisense and gene therapy are therefore dealt with in a single brief chapter.
The author has managed to combine a considerable amount of information in a single volume to provide a useful, basic grounding for the tyro. In particular, the sections on development and manufacture (comprising more than one-third of the content) give the newcomer an understanding of the workings of the product pipeline. This could have been complemented by further discussion of the research technologies in more basic research. A short chapter on the corporate dynamics of the pharmaceutical/biotechnology sector in recent years could also have provided an entertaining addition. At the price, this book provides an informative introduction to the world of biopharmaceutical products and product workflow. David Hughes
Copyright ©1998 Elsevier Science Ltd. All rights reserved. 1461-5347/98/$19.00.
news
PSTT Vol. 1, No. 3 June 1998
Concern over preservatives David Bradley, tel/fax: ⫹44 1954 202218, Web: http://www.camsoft.com/elemental/
Asthma experts have called for a ban on the use of preservatives such as the commonly used benzalkonium chloride and the stabilizer ethylenediamine tetra acetate (EDTA), in medications because of links with increased airway obstruction in sufferers of asthma and chronic pulmonary disease. A review of studies on the use of medications with and without preservatives, could not find any real benefit from their use in terms of reducing bacterial contamination. The researchers in these studies, including Leslie Hendeles (University of Florida College of Medicine, Gainesville, FL, USA), recently discussed the safety implications of these additives in nebulizer solutions, used to treat lung dysfunction, and believe that, rather than
benefiting the patient and preventing infection, they pose a substantial risk by constricting airways and reducing the effectiveness of the medication1. Nebulizer solutions are used in the treatment of asthma, emphysema and chronic bronchitis. Researchers have found that the amount of benzalkonium chloride contained in a standard prescription vial actually leads to constriction of the airways, counteracting the effects of the medication and sometimes worsening lung function in the patient; similar effects were reported for EDTA when higher doses of the stabilizer were inhaled. According to Hendeles, safer, preservative-free medications are available in sterile, single-dose vials and pharmacists, at
least in the USA, tend not to consider the presence of preservatives in a vial and (legally) dispense preservative-containing and preservativefree products as if they were equivalent – often regardless of the specification of the prescribing doctor. Alerted to the problem, the Florida State Board of Pharmacy has drawn attention to the issue in a newsletter, that was sent to pharmacists throughout the state. The more common metered-dose inhalers, which release salbutamol and/or corticosteroids, do not include the preservatives and so, according to the scientists, users are not at risk.
Reference 01
Beasley, R. (1998) Pharmacotherapy 18, 130–139
Book review Biopharmaceuticals: Biochemistry and Biotechnology by Gary Walsh, John Wiley & Sons, 1998. £29.95 (xvi⫹431 pages) ISBN: 0 4719 7789 6
The stated aim of the book is to provide an overview of the science and applications of biopharmaceutical products. A tall order for any single volume. It is targeted at undergraduate and postgraduate students or employees in the industry seeking to gain a wider perspective of the field. Inevitably, given the scope and target markets, there are areas of lightweight coverage and omission. However, the rationale for selective coverage of topics is not always clear; perhaps this represents the coverage of a related coursework programme. For example, Chapter 3 detailing manufacturing processes spans some 80 pages; biopharmaceutical products present a complex set of problems for manufacture, and it is understandable that this section should be extensive. The sec-
94
tion detailing modern approaches to development of pharmaceuticals extends to just under 40 pages and this section incorporates scant coverage of new drug discovery. This itself should have warranted a separate section, given the recent and on-going revolution in advanced technologies such as combinatorial chemistry, high-throughput screening and genomics. The sections focusing on therapeutic agents themselves include extensive coverage of cytokines, growth factors, hormones, blood products and therapeutic enzymes, and antibodies, vaccines and adjuvants. The book focuses on peptide-based therapies, and the major topics of nucleic acid therapeutics, antisense and gene therapy are therefore dealt with in a single brief chapter.
The author has managed to combine a considerable amount of information in a single volume to provide a useful, basic grounding for the tyro. In particular, the sections on development and manufacture (comprising more than one-third of the content) give the newcomer an understanding of the workings of the product pipeline. This could have been complemented by further discussion of the research technologies in more basic research. A short chapter on the corporate dynamics of the pharmaceutical/biotechnology sector in recent years could also have provided an entertaining addition. At the price, this book provides an informative introduction to the world of biopharmaceutical products and product workflow. David Hughes
Copyright ©1998 Elsevier Science Ltd. All rights reserved. 1461-5347/98/$19.00.