Designing wellness. for fun and satisfaction: gummies-based nutrition. By: Andrea Ocampo. Director R&D, Gummies Technology. Procaps S.A.

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1 Designing wellness for fun and satisfaction: gummies-based nutrition By: Andrea Ocampo. Director R&D, Gummies Technology. Procaps S.A.

2 We are Procaps Latin America's largest softgel producer with facilities in Brazil, Colombia and Venezuela, and exports reaching more than 38 countries worldwide. Deep knowledge in gelatin formulation and an impressive scientific expertise in softgel technologies. Specialized in advanced delivery systems such as Unigel TM, Versagels TM, G- tabs TM & Gummygels TM, our nutritional gummies technology. We cater to multinational pharmaceutical clients, including Pfizer, GlaxoSmithKline, Sanofi-Aventis, Boehringer Ingelheim, and Bayer among others.

3 Let s Connect! For more information on our company visit our website or us at softigel@procaps.com.co Follow us on Twitter, Linked in and You tube

4 Table of contents Gummies supplements growth Consumer Preferences Gummy delivery system Product development process Product development key factors

5 Table of contents Gummies supplements growth Consumer Preferences Gummy delivery system Product development process Product development key factors Nutrition is easier when its fun

6 Gummies supplements growth Gummies are an innovative, more attractive alternative to deliver VMS, maintaining the effectiveness of the traditional VMS pill. Gummies or soft chew supplements rank second place in the most commonly used form by consumers, and at the same time are experiencing the largest growth among formats in the category Nutrition is easier when its fun

7 Gummies supplements growth Gummies have moved past multivitamins into almost every segment: fiber, heart health, vision health, prenatal, weight control, sport nutrition, sugar free. Nutrition is easier when its fun It is very surprising the popularity of this format among adults, which it has been doubling sales in this category in the last years.

8 Table of contents Gummies supplements growth Consumer Preferences Gummy delivery system Product development process Product development key factors Nutrition is easier when its fun

9 Consumer preferences No water needed No swallowing difficulties Less gastrointestinal side effects Format that allows to take them anytime, anywhere Replacement for an unhealthy snack or instead of desert A tasty and effective alternative

10 Table of contents Gummies supplements growth Consumer Preferences Gummy delivery system Product development process Product development key factors Nutrition is easier when its fun

11 Gummies delivery system Gummy Benefits Active Convenient and Healthy Product Innovative possibilities Market opportunity to differentiate Consumer friendly and appealing products Alternatives: Non-Animal derived, No GMO, Organic, 100% natural, sustainable, allergen free, sugar free. Added value

12 Gummies delivery system Actives 3 10% Vitamins Minerals Herbal extracts Proteins Omega Water 16 18% Flavor, color, acids Intensive sweeteners 2 4% Bulk-Sweetener Agent 65-75% Sugar/ Corn Syrup Polyalcohols Sugar free Organic Sweetener Tapioca Syrup Rice Syrup Org Cane sugar Gelling agent 1 7% Gelatin Agar-agar Pectin Starch

13 Table of contents Gummies supplements growth Consumer Preferences Gummy delivery system Product development process Product development key factors Nutrition is easier when its fun

14 Product development process Idea Inicial Concept Feasibility Assessment Raw Material Selection Preliminary Formulation Preliminary Prototype Preliminary Validation Flavor and color adjustments Validation Prototype Approval Final Formulation Launch Studies post-approval

15 Table of contents Gummies supplements growth Consumer Preferences Gummy delivery system Product development process Product development key factors Nutrition is easier when its fun

16 Key Factors in Product Development Raw Material Selection Active source. Bio avalability Stability Color and flavor Interaction Base on Scientific bioavailability studies/reports Supplier technical information Results of previous stability analysis

17 Key Factors in Product Development Raw Material Selection Thiamine Benefits: Essential for converting nutrients to energy. Needed for nervous system and normal functionality of muscles Comercial forms: Thiamin hydrochloride (activity=79%) Thiamin Mononitrate (activity 81%) White powder, soluble in water, Mononitrate has poor odor and taste

18 Key Factors in Product Development Raw Material Selection Folic Acid Benefits: Needed for normal growth and development and red blood cell formation. Reduces neural tube birth defect Comercial forms: Folic acid, Metafolin Yellow powder, sparingly soluble in water, low stability in low ph and ligth.

19 Key Factors in Product Development Raw Material Selection The forms currently used in our gummy delivery system are stable at the processing conditions, stability has become a key factor for Bioavailability Interaction, enhancers or inhibitors, the, survival period of lactobacillus is longer in combination with prebiotics such as inulin or FOS

20 Key Factors in Product Development Validation (Preliminary and final) The Gelling agent is defined according. to the target group and the features of the active. Actives and their interaction could modify the ph and the conductivity affecting the setting and the final texture. Getting a final appropriate texture and setting imply a mixture between knowledge and empirical trials

21 Key Factors in Product Development Validation (Preliminary and final) Laboratory Testing Method: sample preparation, extraction and appropriate valuation method. Laboratory internal source and co-work with suppliers - raw materials and laboratory services

22 Key Factors in Product Development Validation (Preliminary and final) Stability testing is to provide evidence of how the active quality varies with time under the influence of a variety of environmental factors and the product-related factors: interaction with excipients, packaging materials, and the interaction between two or more actives. Calcium pantothenate is one the most labile vitamins,in these case, encapsulated form and an overage is necessary to guarantee the label claim along the shelf life. Degree of stability in production and shelf life is a key factor in the availability for use in human body.

23 Additional Facts Some reports have determined that supplementation at preventive intake levels can reduce the number of medical events associated with heart disease, agerelated eye disease, diabetes and bone disease in US. (Frost & Sullivan 2014). VMS Consumers are aware of the health benefits and Gummies are an excellent alternative offering a pleasant and fun experience combined with efficacy and convenience. Based on the design and development process, we review in detail the stage of selection of materials and validation as critical phases in obtaining a product of highest quality and stability while considering the specific requirements of the customer and end user.

24 At Procaps

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26 References Hutkins, R. Persistence of Probiotics in the Gastrointestinal Tract and the Role of Synbiotics Johnsen, M. More shelf space linked to higher VMS sales. Droug Store News Johnsen, M. Gummy vitamins, nutritional benefits rise. Droug Store News Herrera, J. Aspectos preventivos de la ingesta de calcio en los diferentes ciclos vitales del ser humano. Colombia Médica. Vol. 33 Nº 1, 2002 U.S. Department of Health and Human Services. Food and Drug Administration. Guidance for Industry Process Validation: General Principles and Practices World Health Organization. WHO Technical Report Series, No. 953, 2009

27 For more information visit or us at Thank You! Grazie Mille! Gracias!