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An automatic dose dispenser for microtablets: A new concept for individual dosage of drugs in tablet form
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
2003 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, Vol. 261, no 1-2, 137-146 p.Article in journal (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.

Place, publisher, year, edition, pages
2003. Vol. 261, no 1-2, 137-146 p.
Keyword [en]
Individual dosage, Drug dispensing device, Parkinson’s disease, Levodopa, Microtablets
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-90434DOI: 10.1016/S0378-5173(03)00294-1ISI: 000184607500013OAI: oai:DiVA.org:uu-90434DiVA: diva2:162787
Available from: 2003-04-23 Created: 2003-04-23 Last updated: 2014-01-29Bibliographically approved
In thesis
1. 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
Open this publication in new window or tab >>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)Doctoral thesis, comprehensive summary (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, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2003. 83 p.
Series
Comprehensive Summaries of Uppsala Dissertations from the Faculty of Pharmacy, ISSN 0282-7484 ; 287
Keyword
Pharmaceutics, Interactive mixture, Dose homogeneity, Disintegration, Bioadhesion, Oromucosal delivery, Sublingual tablet, Rapid absorption, Individual dosage, Drug dispensing device, Galenisk farmaci
National Category
Pharmaceutical Sciences
Research subject
Pharmaceutics
Identifiers
urn:nbn:se:uu:diva-3433 (URN)91-554-5600-6 (ISBN)
Public defence
2003-05-15, B21, BMC, Uppsala, 13:15
Opponent
Supervisors
Available from: 2003-04-23 Created: 2003-04-23Bibliographically approved
2. Pharmacotherapy for Parkinson's Disease - Observations and Innovations
Open this publication in new window or tab >>Pharmacotherapy for Parkinson's Disease - Observations and Innovations
2003 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Pharmacotherapy for Parkinson’s disease (PD) is based on levodopa, the most effective dopaminergic drug. The development of motor complications constitutes the major challenge for new or refined therapies.

To evaluate the impact of levodopa pharmacokinetics on motor function, an observational study in the patients’ home environment was carried out. A high variability in plasma levodopa levels was found in all patients, irrespective of treatment regimen. The impact of levodopa pharmacokinetics was further studied in a crossover trial comparing sustained-release tablets and continuous daytime intestinal infusion. Infusion produced significantly decreased variability in plasma levels of levodopa, resulting in significantly normalised motor function. A permanent system for long-term levodopa infusion has been developed and 28 patients have been followed for 87 patient-years. Motor response was generally preserved during the long-term observation period, implying that there is no development of tolerance to infusion therapy. Levodopa tablets are normally used in multiples of 50 or 100 mg, thus a rough estimate of individual dosage. A new concept for individualising levodopa/carbidopa doses with microtablets of 5/1.25 mg is under development. An electronic drug-dispensing device for administering the microtablets was tested on patients with PD. All were able to handle the dispenser and most were interested in future use of the concept. Self-assessment of symptoms is accurate in PD, but traditional paper diaries are associated with low compliance. A wireless electronic diary was compared with a corresponding paper diary. The time-stamped and thus completely reliable patient compliance was 88% with the electronic diary.

To conclude, pharmacokinetics of levodopa is the major determinant for motor fluctuations in PD. Every effort to individualise dosage and to smooth out the fluctuations in levodopa concentrations should be made, e.g. by means of microtablets or enteral infusion. Electronic patient diaries for real-time data capture are suitable for PD studies.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2003. 99 p.
Series
Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 0282-7476 ; 1236
Keyword
Neurosciences, Parkinson's disease, levodopa, pharmacokinetics, infusion, drug delivery systems, electronic patient diary, Neurovetenskap
National Category
Neurology
Research subject
Neurology
Identifiers
urn:nbn:se:uu:diva-3354 (URN)91-554-5571-9 (ISBN)
Public defence
2003-05-06, Grönwallsalen, entrance 70, Uppsala University Hospital, Uppsala, 13:15
Opponent
Supervisors
Available from: 2003-04-10 Created: 2003-04-10 Last updated: 2014-01-29Bibliographically approved

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Bredenberg, SusanneNyholm, DagAquilonius, Sten-Magnus

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