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Pharmaceutical technological aspects and possibility of using transdermal patches in paediatric population

Bibliographic Details
Title: Pharmaceutical technological aspects and possibility of using transdermal patches in paediatric population
Authors: Đekić Ljiljana, Živković Sanja, Primorac Marija
Source: Arhiv za farmaciju, Vol 64, Iss 4, Pp 349-374 (2014)
Publisher Information: Pharmaceutical Association of Serbia, Belgrade, Serbia, 2014.
Publication Year: 2014
Collection: LCC:Pharmacy and materia medica
Subject Terms: transdermal drug delivery, transdermal patches, paediatric population, regulation (ec) 1901/2006, guideline ema/chmp/qwp/805880/2012, Pharmacy and materia medica, RS1-441
More Details: The administration of drugs via skin to achieve systemic effects is simple and noninvasive, and thus represents a more suitable alternative for pediatric population when compared with per os and parenteral routes. This pharmaceutical dosage form provides a controlled drug release and subsequent reduction in the frequency of administration and increased patient adherence. In 2006, the Food and Drug Administration (FDA) approved the use of a transdermal patch with methylphenidate, which is designed for the pediatric population. Transdermal patches with an opioid analgesic (fentanyl, buprenorphine), clonidine, scopolamine, tulobuterol, estrogens and nicotine, have been developed for use by adult patients, and have been registered for the use in children of a certain age, and/or the literature described the clinical studies or examples in practice of their off label use with respect to the age of the patient, the dose and/or indications. The Regulation (EC) 1901/2006 on medicinal products for paediatric use and the Guideline on pharmaceutical development of medicines for pediatric use EMA/CHMP/QWP/805880/2012 pointed out that design of transdermal patches requires careful consideration of: specificities in development and the variation of the skin barrier function, the choice of excipients with consideration of their potential for irritation or sensitization of the skin, the range of the quantity of drug which is released per unit of time and the surface on which the drug release is performed (as well as the overal size of a transdermal patch), which should be adequate to meet the individual therapeutic needs of children of different ages.
Document Type: article
File Description: electronic resource
Language: Serbian
ISSN: 0004-1963
2217-8767
Relation: https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2014/0004-19631404349D.pdf; https://doaj.org/toc/0004-1963; https://doaj.org/toc/2217-8767
DOI: 10.5937/arhfarm1404349D
Access URL: https://doaj.org/article/aa1e11bec8f445dd8c095d5407321663
Accession Number: edsdoj.1e11bec8f445dd8c095d5407321663
Database: Directory of Open Access Journals
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  Data: Pharmaceutical technological aspects and possibility of using transdermal patches in paediatric population
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  Data: <searchLink fieldCode="AR" term="%22Đekić+Ljiljana%22">Đekić Ljiljana</searchLink><br /><searchLink fieldCode="AR" term="%22Živković+Sanja%22">Živković Sanja</searchLink><br /><searchLink fieldCode="AR" term="%22Primorac+Marija%22">Primorac Marija</searchLink>
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  Data: Arhiv za farmaciju, Vol 64, Iss 4, Pp 349-374 (2014)
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  Data: Pharmaceutical Association of Serbia, Belgrade, Serbia, 2014.
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  Data: <searchLink fieldCode="DE" term="%22transdermal+drug+delivery%22">transdermal drug delivery</searchLink><br /><searchLink fieldCode="DE" term="%22transdermal+patches%22">transdermal patches</searchLink><br /><searchLink fieldCode="DE" term="%22paediatric+population%22">paediatric population</searchLink><br /><searchLink fieldCode="DE" term="%22regulation+%28ec%29+1901%2F2006%22">regulation (ec) 1901/2006</searchLink><br /><searchLink fieldCode="DE" term="%22guideline+ema%2Fchmp%2Fqwp%2F805880%2F2012%22">guideline ema/chmp/qwp/805880/2012</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmacy+and+materia+medica%22">Pharmacy and materia medica</searchLink><br /><searchLink fieldCode="DE" term="%22RS1-441%22">RS1-441</searchLink>
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  Data: The administration of drugs via skin to achieve systemic effects is simple and noninvasive, and thus represents a more suitable alternative for pediatric population when compared with per os and parenteral routes. This pharmaceutical dosage form provides a controlled drug release and subsequent reduction in the frequency of administration and increased patient adherence. In 2006, the Food and Drug Administration (FDA) approved the use of a transdermal patch with methylphenidate, which is designed for the pediatric population. Transdermal patches with an opioid analgesic (fentanyl, buprenorphine), clonidine, scopolamine, tulobuterol, estrogens and nicotine, have been developed for use by adult patients, and have been registered for the use in children of a certain age, and/or the literature described the clinical studies or examples in practice of their off label use with respect to the age of the patient, the dose and/or indications. The Regulation (EC) 1901/2006 on medicinal products for paediatric use and the Guideline on pharmaceutical development of medicines for pediatric use EMA/CHMP/QWP/805880/2012 pointed out that design of transdermal patches requires careful consideration of: specificities in development and the variation of the skin barrier function, the choice of excipients with consideration of their potential for irritation or sensitization of the skin, the range of the quantity of drug which is released per unit of time and the surface on which the drug release is performed (as well as the overal size of a transdermal patch), which should be adequate to meet the individual therapeutic needs of children of different ages.
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      – Text: Serbian
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      – SubjectFull: transdermal drug delivery
        Type: general
      – SubjectFull: transdermal patches
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      – SubjectFull: paediatric population
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