applications for sensory science to … · science to pharmaceutical and nutraceutical ... –...

APPLICATIONS FOR SENSORY SCIENCE TO

PHARMACEUTICAL AND NUTRACEUTICAL PRODUCTS

25 May 2005

Anne GoldmanDirector of Consumer Guidance Research

ACCEMississauga Ontario Canada

May 20052

ESN Presentation - A. Goldman

SUMMARY

• BACKGROUND• HISTORY• COMPLIANCE• SAFETY CONSIDERATIONS• SENSORY METHODS• IRB• PROTOCOL DEVELOPMENT• CASE STUDIES• OPPORTUNITIES GOING FORWARD

May 20053


BACKGROUND

• PHARMACEUTICALS– DEATH PREVENTION

• NUTRACEUTICALS– HEALTH RETENTION

GROWTH - Aging Demographics, Attention to Health

May 20054


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 20055


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 20056


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 20057


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 20058


SENSORY SCIENCE AND THE DEVELOPMENT CYCLE

Product Idea

Marketing Plan

Research & Clinical

Development Production Sales Distribution Post-Launch

Sensory Science

Maturity & Decline

GrowthInfancy - - - - - - - - - - - - - - - - - - - - -

May 20059


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 200510


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 200511


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 200512


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 200513


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 200514



• Interviewing the study subjects

May 200515



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 200516



• Children like more intense blue/red colours than pale yellow or no colour

6.2

6.1

6.0

5.8

5.6

5.3

4.7

4.3

Purple

Cherry/Red

Red

Green

Pale Purple

Pale orange

Pale yellow

No colour

Opinion of liking of colour - fever medicationAverage mean scores, 1=dislike a whole lot 7 = like a whole lot

May 200517


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.

.

May 200518


FLAVOURHealth Benefits

Convenience

Quality

CASE STUDY – STANOL MARGARINE

May 200519



• 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 200520



• 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 200521


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

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