| Description |
1 online resource |
| Series |
Advances in pharmaceutical technology |
| Contents |
Oral Dosage Forms. Lipid-Based Oral Formulations / Murat Kilic, Aikaterini Avzoti, Jennifer Dressman, Christos Reppas -- Chewable Oral Drug Products / Johannes Krämer, Jayachandar Gajendran, Alexis Guillot, Abdulwahab Barakat -- Non-oral Dosage Forms. Injectables / Susan D'Souza -- Drug-Eluting Stents / Anne Seidlitz -- In Vitro Dissolution for Inhalation Products / Annalisa Mercuri, Nikoletta Fotaki -- Topicals and Transdermals / Kailas Thakker -- Vaginal and Intrauterine Delivery Systems / Sandra Klein, Katharina Tietz -- Rectal Dosage Forms / Sandra Klein -- Ophthalmic Dosage Forms / Christian Simroth-Loch, Werner Weitschies, Clive G Wilson -- Regulatory Considerations / Vivian A Gray |
| Summary |
"In the mid 1960s people realized that drug dissolution/release has a significant impact on the therapeutic effect of orally administered drugs. Both the United States Food and Drug Administration (FDA) and United States Pharmacopoeia introduced dissolution requirements for oral drug products and the first dissolution tests became a quality control (QC) tool to ensure batch-to-batch consistency. As a consequence, from the 1970s on, several dissolution test methods were adopted as official QC methods for solid oral dosage forms. In the late 1990s, the increasing number of official dissolution apparatus and dissolution methods in the USP was complemented by the release of various FDA guidances pertaining to in vitro dissolution testing of solid oral dosage forms and its application from a regulatory point of view. Since then dissolution/drug release testing has expanded considerably with a variety of apparatus and methods in international pharmacopoeia and numerous international guidances and nowadays not only addresses questions of quality control but also plays an important role in screening of formulations and is also an important tool in proving bioequivalence of different drug products"-- Provided by publisher |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record and CIP data provided by publisher |
| Subject |
Drugs -- Dosage forms.
|
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Oral medication.
|
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Solid dosage forms.
|
|
Drugs -- Dosage forms.
|
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Oral medication.
|
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Solid dosage forms.
|
| Form |
Electronic book
|
| Author |
Fotaki, Nikoletta, 1973- editor.
|
|
Klein, Sandra, 1970- editor.
|
| LC no. |
2019024445 |
| ISBN |
1118675746 |
|
1118675770 |
|
1118675835 |
|
9781118675748 |
|
9781118675779 |
|
9781118675830 |
|
