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New Concepts in Administration of Drugs in Tablet Form : Formulation and Evaluation of a Sublingual Tablet for Rapid Absorption, and Presentation of an Individualised Dose Administration System
2003 (English)Doktorsavhandling, sammanläggning (Other academic)
Abstract [en]

This thesis presents two new concepts in oral drug administration and the results of evaluation of some relevant formulation factors.

Investigation into improving the homogeneity of mixtures for tableting indicated that it may be possible to obtain interactive dry mixtures of micronised drugs containing drug proportions as low as 0.015% w/w. By studying the relationship between disintegration time and tensile strength, it was found that the microstructure surrounding the disintegrant particles may influence the disintegration process. Therefore, avoidance of excipients which are highly deformable or very soluble in water will result in more rapid disintegration. Further, it is possible to increase the bioadhesive properties of a non-bioadhesive carrier material by forming interactive mixtures containing a fine particulate bioadhesive material.

The new sublingual tablet concept presented is based on interactive mixtures consisting of a water-soluble carrier covered with fine drug particles and a bioadhesive component. With this approach, it is possible to obtain rapid dissolution in combination with bioadhesive retention of the drug in the oral cavity. Clinical data indicate that this allows rapid sublingual absorption while simultaneously avoiding intestinal absorption.

An individualised dose administration system is also presented. This system is based on the use of standardised units (microtablets), each containing a sub-therapeutic amount of the active ingredient. The required dose is fine-tuned by electronically counting out a specific number of these units using an automatic dose dispenser. A patient handling study supported the suggestion that the dosage of some medications can be more easily and safely individualised for each patient with this method than by using traditional methods of mixing different standard tablet strengths or dividing tablets.

Place, publisher, year, pages
Uppsala: Acta Universitatis Upsaliensis, 2003. 83 p.
Series
Comprehensive Summaries of Uppsala Dissertations from the Faculty of Pharmacy, ISSN 0282-7484 ; 287
Keyword [en]
Pharmaceutics, Interactive mixture, Dose homogeneity, Disintegration, Bioadhesion, Oromucosal delivery, Sublingual tablet, Rapid absorption, Individual dosage, Drug dispensing device
Keyword [sv]
Galenisk farmaci
National Category
Pharmaceutical Sciences
Research subject
Pharmaceutics
Identifiers
urn:nbn:se:uu:diva-3433 (URN)91-554-5600-6 (ISBN)oai:DiVA.org:uu-3433 (OAI)
Public defence
2003-05-15, B21, BMC, Uppsala, 13:15
Opponent
Supervisors
Available from2003-04-23 Created:2003-04-23Bibliographically approved
List of papers
1. The possibility of achieveing an interactive mixture with high dose homogeneity containing an extremely low proportion of a micronised drug
Open this publication in new window or tab >>The possibility of achieveing an interactive mixture with high dose homogeneity containing an extremely low proportion of a micronised drug
2001 In: European Journal of Pharmaceutical Sciences, Vol. 12, 285-295Artikel i tidskrift (Refereed) Published
Identifiers
urn:nbn:se:uu:diva-90429 (URN)
Available from2003-04-23 Created:2003-04-23Bibliographically approved
2. Formulation of high tensile strength rapidly disintegrating tablets
Open this publication in new window or tab >>Formulation of high tensile strength rapidly disintegrating tablets : Evaluation of the effect of some binder properties
2001 In: S.T.P. Pharma Sciences, Vol. 11, no 3, 211-220Artikel i tidskrift (Refereed) Published
Identifiers
urn:nbn:se:uu:diva-90430 (URN)
Available from2003-04-23 Created:2003-04-23Bibliographically approved
3. In-vitro evaluation of bioadhesion in particulate systems and possible improvement using interactive mixtures
Open this publication in new window or tab >>In-vitro evaluation of bioadhesion in particulate systems and possible improvement using interactive mixtures
2003 In: Journal of Pharmacy and Pharmacology, ISSN 0022-3573, Vol. 55, 169-177Artikel i tidskrift (Refereed) Published
Identifiers
urn:nbn:se:uu:diva-90431 (URN)
Available from2003-04-23 Created:2003-04-23Bibliographically approved
4. In-vitro and pharmacokinetic evaluation of a new sublingual tablet system for rapid oromucosal absorption using fentanyl citrate as the active substance
Open this publication in new window or tab >>In-vitro and pharmacokinetic evaluation of a new sublingual tablet system for rapid oromucosal absorption using fentanyl citrate as the active substance
Show others...
Artikel i tidskrift (Refereed) Submitted
Identifiers
urn:nbn:se:uu:diva-90432 (URN)
Available from2003-04-23 Created:2003-04-23Bibliographically approved
5. Clinical pharmacokinetics and safety of fentanyl following sublingual administration of a rapidly dissolving tablet in cancer patients: a new approach for treating incident pain
Open this publication in new window or tab >>Clinical pharmacokinetics and safety of fentanyl following sublingual administration of a rapidly dissolving tablet in cancer patients: a new approach for treating incident pain
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Manuskript (Other academic)
Identifiers
urn:nbn:se:uu:diva-90433 (URN)
Available from2003-04-23 Created:2003-04-23 Last updated:2010-01-13Bibliographically approved
6. An automatic dose dispenser for microtablets
Open this publication in new window or tab >>An automatic dose dispenser for microtablets : A new concept for individual dosage of drugs in tablet form
2003 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, Vol. 261, no 1-2, 137-146Artikel i tidskrift (Refereed) Published
Abstract [en]

A new concept for individualising the dosage of drugs in solid form is presented. The principle is based on the use of standardised units (microtablets), each containing a subtherapeutic amount of the active ingredient. The required dose is fine-tuned by counting out a specific number of these units. The microtablets are counted electronically from the attached cassette by the automatic dispensing device. The individual dose is set and the dispenser counts and delivers the correct number of microtablets. The usefulness of the automatic dispenser concept and acceptability of the apparatus were evaluated in patients with Parkinson’s disease (PD). After initial instruction on use of the dispenser, 20 patients operated it themselves. All patients were generally satisfied with their management of the automatic dispenser and most would be happy to use the device again. Further technical development is required before use in clinical practice, but the current prototype may be acceptable for some patients. It is concluded that the final version of the automatic dose dispenser concept will offer potential for improvement of drug administration for patients with PD or other diseases requiring individual dosage.

Keyword
Individual dosage, Drug dispensing device, Parkinson’s disease, Levodopa, Microtablets
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-90434 (URN)10.1016/S0378-5173(03)00294-1 (DOI)000184607500013 (ISI)
Available from2003-04-23 Created:2003-04-23 Last updated:2014-01-29Bibliographically approved

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