UWA technology licensing/
partnering opportunity
Novel formulation to mask drug bitterness
Researchers at the University of Western Australia have developed a chocolate based, pharmaceutical formula that masks the taste of bitter drugs such as midazolam, tramadol and clindamycin thereby ensuring therapeutic compliance with minimal distress in young children, the elderly or patients with dysphagia.
Problem
To achieve the benefits of a medicine, the patient must be willing to take it in the correct amount at the appropriate time. Most medicines are not formulated for use in children and extemporaneous formulations are untested, inconsistent and quite unstable. For those medicines that are formulated for children, few are considered sufficiently palatable.
Drugs where medication adherence is of paramount importance yet are rarely tolerated by children, including antibiotics, steroids, pain medication and cystic fibrosis medication, provide a substantial unmet need.
- Each year, millions of infants and children require sedation for medical and dental procedures. Practitioners struggle to achieve "successful sedation" while preventing or avoiding adverse events, in particular from receiving incorrect dosage. The incidence of "failed sedation" is reported to be up to 50% of patients.
- Clindamycin for treatment of skin and soft tissue infections is an extremely bitter compound which is difficult to mask with foods or liquids and commonly met with a great deal of resistance and refusal from children.
Solution
We have developed a mini-tablet formulated using a novel combination of commonly used, safe, pharmaceutical ingredients and chocolate. This formulation masks the bitterness of the drug to increase compliance without altering the way the drug affects the children, thereby providing a safer and more effective method of dosing children for surgery and dental procedures.
The formulation has an impressive number of novel features of appeal to patients, clinicians and parents managing paediatric patients which include: greater dose accuracy, flexibility, ease of administration (mini chewable tablet measuring just 10x5x5 mm or 10x10x5 mm depending on dosing needs), stability on storage at ambient temperature (>18 months) and taste masking effectiveness.
Stage of development
Proof of concept has been established on the first two products. This is a stable, chewable mini-tablet that contains either 5 mg midazolam hydrochloride or 10 mg tramadol with flexible yet accurate dosing ability (score lines).
Assessments of the midazolam and tramadol productsinclude:
(i)Drug Content and Content Uniformity
(ii)Stability Data to 18 months at room temperature
(iii)In vitro drug dissolution profile
(iv)Taste evaluation in a standard animal model
(v)Taste evaluation in paediatric patients
(vi)Pharmacokinetic and pharmacodynamic (and some safety) data in >100 paediatric patients to date.*
* For midazolam. The pediatric tramadol study is still underway.
This formulation does not affect the PK of the drug; is stable at room temperature for at least 18 months with no effect on drug content and has been demonstrated to effectively provide palatable formulations for bitter drugs to assist clinicians achieve the desired therapeutic outcomes in paediatric patients.
Intellectual Property
A provisional patent application has been developed to provide market exclusivity for both the formulation and the method of manufacture.
The Team
Prof Lee Yong Lim is a pharmaceutical scientist at UWA Pharmacy department.
Prof. Britta Regli-Von Ungern-Sternberg is a paediatric anesthesia specialist at Princess Margaret Hospital for Children.
Dr Sam Salman is a clinical pharmacologist (Fiona Stanley Hospital and School of Medicine & Pharmacology UWA) and consultant with Linear Clinical Research Ltd (CRO).
UWA is seeking a commercial partner to in-licence and develop this technology.
Commercial Correspondence
Dr Samantha South
Senior Commercialisation Officer
Research Development and Innovation
The University of Western Australia
Tel: +61 6488 3905
Email: