Applications for Sensory Science to Pharmaceutical
n a m d Guidance Research ACCE Anne Gol 25 May 2005
SCIENCE TO Mississauga Ontario Canada Director of Consumer
PHARMACEUTICAL AND
NUTRACEUTICAL PRODUCTS APPLICATIONS FOR SENSORY SUMMARY
• BACKGROUND • HISTORY • COMPLIANCE • SAFETY CONSIDERATIONS • SENSORY METHODS • IRB • PROTOCOL DEVELOPMENT • CASE STUDIES • OPPORTUNITIES GOING FORWARD
May 2005 ESN Presentation - A. Goldman 2 BACKGROUND
• PHARMACEUTICALS – DEATH PREVENTION
• NUTRACEUTICALS – HEALTH RETENTION
GROWTH - Aging Demographics, Attention to Health
May 2005 ESN Presentation - A. Goldman 3 HISTORY
• THE FOOD INDUSTRY HAS A LONG HISTORY WITH SENSORY ANALYSIS 1960s • PHARMACEUTICAL INDUSTRY 1990s with some exceptions: • McNeil – Splenda, Benecol • Glaxo Smith Kline - Lucozade • Novartis – Gerber Baby Foods • Pfizer – Halls, Listerine • SENSORY ANALYSIS ASSOCIATED MAINLY WITH NON PRESCRIPTION DRUG PRODUCTS • AND NUTRACEUTICAL PRODUCTS
May 2005 ESN Presentation - A. Goldman 4 COMPLIANCE
• COMPLIANCE IS COMPROMISED IF SENSORY PROPERTIES ARE UNACCEPTABLE
• BITTER ACTIVE INGREDIENT – TASTE COMPROMISED • UNPALATABLE TEXTURE (grittiness, tablet size and shape) – SWALLOWING COMPROMISED
• A HEALTH OR THERAPEUTIC BENEFIT WILL NOT NECESSARILY COMPENSATE FOR AN UNACCEPTABLE SENSORY EXPERIENCE
May 2005 ESN Presentation - A. Goldman 5 CLINICAL TRIALS
• TO SUBSTANTIATE SAFETY & EFFECTIVENESS
• THREE PHASES – Phase I – preclinical – safety – optimal dosage – Phase II – large scale patient trial - effectiveness – Phase III – proceeds after passing Phases I and II – testing against placebo • Proceeds to regulatory approval • Gather sensory/consumer data for marketing purposes
May 2005 ESN Presentation - A. Goldman 6 GOOD CLINICAL PRACTICE (GCP)
• INTERNATIONAL ETHICAL AND QUALITY STANDARD – DESIGNING, CONDUCTING, RECORDING & REPORTING TRIALS INVOLVING HUMANS – COMPLIANCE PROVIDES ASSURANCE THAT THE RIGHTS,SAFETY & WELL BEING OF SUBJECTS ARE PROTECTED – STUDY DATA ARE CREDIBLE
May 2005 ESN Presentation - A. Goldman 7 SENSORY SCIENCE AND THE DEVELOPMENT CYCLE
Research & Clinical Product Marketing Idea Plan Development Production Sales Distribution Post- Launch
Sensory Science
Infancy ------Growth ------Maturity & Decline
May 2005 ESN Presentation - A. Goldman 8 SENSORY METHODS
• DESCRIPTIVE SENSORY – Characterise the sensory profile – Highlight attributes of concern – Benchmark against controls – Discrimination
• CONSUMER STUDIES – Degree of like/dislike – Acceptable sensory dimensions – Likelihood for compliance – Market potential
May 2005 ESN Presentation - A. Goldman 9 INSTITUTIONAL REVIEW BOARD (IRB)
• PRIMARY PURPOSE – To protect human subjects from improperly designed research • SECONDARY PURPOSE – Evaluate the risk to benefit ratio • 5 or MORE MEMBERS – At least one with a scientific and one with a non- scientific background, no conflict of interest • REVIEWS – STUDY PROTOCOL, SAFETY SUMMARY, FORMUALTIONS, INFORMED CONSENT, INVESTIGATOR CREDENTIALS
May 2005 ESN Presentation - A. Goldman 10 PROTOCOL DEVELOPMENT
• INTRODUCTION – study background, safety information and rationale • OBJECTIVE – use of the results • STUDY DESIGN – experimental design • STUDY POPULATION – inclusion & exclusion criteria • STUDY MATERIALS – product description, handling • STUDY PROCEDURES – screening,informed consent, number of study visits, evaluation method, withdrawal • ADVERSE EVENTS – procedures, 24 hour contact • ETHICAL ASPECTS – investigator, nurse, IRB, informed consent • ADMINISTRATIVE – record retention, use of study
May 2005 ESN Presentation - A. Goldman 11 THE INFORMED CONSENT DOCUMENT
• STATEMENT OF RESEARCH • REASONABLY FORESEEABLE RISKS • BENEFITS TO SUBJECTS • CONFIDENTIALITY OF RECORDS • COMPENSATION & TREATMENT FOR INJURY • VOLUNTARY PARTICIPATION STATEMENT • RISKS THAT ARE UNFORESEEABLE • CIRCUMSTANCES FOR TERMINATION • WITHDRAWAL & TERMINATION • NEW FINDINGS & FURTHER STUDY • APPROXIMATE NUMBER OF SUBJECTS
May 2005 ESN Presentation - A. Goldman 12 CASE STUDY – CHILD’S FEVER MEDICATION
• PARENTAL & CHILD CONSENT • CATEGORY & BRAND USERS • SUBJECTS IN GOOD HEALTH • NO HISTORY OF ALLERGIC REACTION TO ANY INGREDIENT IN THE TEST PRODUCTS • NO MEDICATION AT THE TIME OR 48 HOURS PRECEDING THE STUDY • TEST AMOUNT – TOTAL = LESS THAN ONE DAILY DOSAGE FOR YOUNGEST CHILD IN THE STUDY
May 2005 ESN Presentation - A. Goldman 13 CASE STUDY – CHILD’S FEVER MEDICATION
• Interviewing the study subjects
May 2005 ESN Presentation - A. Goldman 14 CASE STUDY – CHILD’S FEVER MEDICATION
DATA COLLECTION – CHILD FRIENDLY SCALES
• OPINION OF TASTE • TAKE WHEN YOU ARE SICK? • INTERVIEWER OBSERVATIONS AS CHILD TASTES • AS WELL AS: – COLOUR – SMELL – SWEETNESS – FLAVOUR IDENTITY/DESCRIPTION
May 2005 ESN Presentation - A. Goldman 15 CASE STUDY – CHILD’S FEVER MEDICATION
• Children like more intense blue/red colours than pale yellow or no colour
Purple 6.2
Cherry/Red 6.1
Red 6.0
Green 5.8
Pale Purple 5.6
Pale orange 5.3
Pale yellow 4.7
No colour 4.3
Opinion of liking of colour - fever medication Average mean scores, 1=dislike a whole lot 7 = like a whole lot May 2005 ESN Presentation - A. Goldman 16 PRODUCT CLAIM - CHILDREN’S FEVER TABLETS
Now Children's Tylenol™ comes in a new form that kids love! New Children's Tylenol™ Meltaways. Fast relief that melts in your child's mouth—in yummy Grape Punch, Wacky Watermelon, and Bubblegum Burst. Meltaways are easy to give—no spoon and no water needed. And easy to take. Kids prefer it.
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May 2005 ESN Presentation - A. Goldman 17 CASE STUDY – STANOL MARGARINE
Convenience
Health Benefits FLAVOUR
Quality
May 2005 ESN Presentation - A. Goldman 18 CASE STUDY – STANOL MARGARINE
• CATEGORY & BRAND USERS • Have concerns about their cholesterol and manage their cholesterol intake by diet not medication • SUBJECTS IN GOOD HEALTH • NO HISTORY of or active gastro intestinal disease or have had an intestinal surgery • NO MEDICATION OR SUPPLEMENTS AT THE TIME OR 48 HOURS PRECEDING THE STUDY • WILLING TO SIGN AN INFORMED CONSENT
May 2005 ESN Presentation - A. Goldman 19 CASE STUDY – STANOL MARGARINE
• PROTOTYPE & SHELF LIFE TESTING – Test prototypes containing stanol ingredient against control margarine – Descriptive sensory panel • CONSUMER TESTING – CLT Prototype v Control for acceptance on bread – HUT prior to market introduction
May 2005 ESN Presentation - A. Goldman 20 OPPORTUNITIES GOING FORWARD
• AREA OF GROWTH - increased consumer involvement with health maintenance as population ages • PHARMACEUTICALS - recognition of sensory issues in the early stages of clinical development to improve product compliance issues • NUTRACEUTICALS – optimise sensory properties for consumer acceptance. Health benefits will not be enough to ensure market success • FUTURE RESEARCH - better understanding of masking agents and bitterness blockers – taste receptor research,as well as disease effects on sensory perception
May 2005 ESN Presentation - A. Goldman 21