Tablets that melt in the mouth:

Transcription

1 Tablets that melt in the mouth: formulations for the future Dr Afzal R Mohammed a.u.r.mohammed@aston.ac.uk A. R. Mohammed Slides are for personal use only. They are NOT for reproduction or publication

2 Introduction Medication non adherence can be due to multiple factors: Physiological factors type of disease, depression, symptoms, physiological variables (e g: dysphagia) Prevalence percentage 70% 60% 50% 40% 30% 20% 10% 0% Short term care Individuals older than 50 Nursing house occupants Disease related dysphagia Cook. I.J., Kahrilas, P.J., (1999), AGA Technical Review on Management of Oropharyngeal Dysphagia., Gastroenterology Behavioral factors social, religious and health beliefs, economic conditions Treatment factors duration and complexity of the medication regime, lack of patient specific formulations

3 Orally disintegrating tablets (tablets that melt in the mouth) Orally disintegrating tablets (ODTs) are solid dosage forms that are placed in the mouth, rapidly disintegrate/dissolve when contact with the saliva and then easily swallowed without drinking water (European pharmacopoeia, 2002) Provide rapid onset of action Convenient and practical dosage all the time especially in case of no access to water Can be used to deliver different types of drugs

4 Lyophilised ODTs in Action

5 General Formulation Binder Active molecule Filler A schematic illustration of the general formulation of freeze-dried ODT.

6 Research at ARCHA Overarching aim of our research is to further develop tablets that melt in the mouth to increase medication adherence by: Overcoming physiological barriers such as dysphagia tablets with low solid content and rapid disintegration New materials as binders, fillers (amino acids, polymers) Develop simplified manufacturing protocols Develop high through put technologies for product development Addressing behavioural factors - develop formulations that will be acceptable to patient population with different social and religious beliefs Investigation of novel polymers Treatment factors develop tablets that can deliver multiple drugs over prolonged duration Develop novel delivery approaches

7 Progress so far... Research symposia presentations 5 Research funding Orally disintegrating tablets Patents 2 Research publications 8

8 Patent ACH/P108627GB00-16 th November 2009 Formulation of non-gelatine based orally disintegrating tablets Gelatine and sugar free tablets Scalable manufacturing protocol Reduced cost of production Capable of delivering wide range of drugs Acceptable to patient population with different religious beliefs

9 Patent SCB/HMC/P111450GB00-9 th April 2010 Formulation of multiparticulate drug delivery systems in lyophilised ODT formulations. Freeze drying produces ODTs without application of any compaction force. Extend the application of ODTs to more challenging drugs: Mask the unpleasant taste of active drugs. Protect acid-labile drugs. Provide controlled drug release. Combine the benefits of ODTs and multiparticulate systems: Reduced risk of systemic toxicity. Enhanced bioavailability. Reduced risk of local irritation and patient to patient variability. Cross section of lyophilised ODTs containing pellets Instant disintegration after addition of few drops of water

10 Current research Tablets that can deliver drugs over longer duration Development of hybrid formulation technology which combines orally disintegrating tablet platform with sustained drug delivery Tablets capable of delivering poly pharmacy Development of novel manufacturing methods to deliver multiple drugs Systematic investigation of new materials and processes

11 Our research team Previous Students Farhan Alhusban - PhD Sheraz Khan - PhD Rahul Chandrasekhar Zahra Hassan Sherif ElSamman Present Students Amr ElShaer Craig Russell Rhys Jones Anjumn Shabir Ali Al-Khattawi