GUMMY

YUMMY C
“ H E A LT H Y I N S I D E , F R E S H O U T S I D E ”
 INTRODUCTION

1. Head Of Department : Ranti Yunitasari 3311161033

2. Research and Development : Assyifa Safilla 3311161034
Penny Andryani 3311161050
3. Clinical Affairs : Nandi Agustian 3311161001
4. Production : Nabilla Zhafira 3311161081
5. Quality Assurance : Nida Fauzia 3311161020
6. Regulatory Affairs : Hera S 3311161083
7. Marketing and Sells : Eka Irma 3311161023

GROUP 10
RESEARCH AND DEVELOPMENT
 VITAMIN C (ASCORBIC ACID)

• Vitamin C is a critical component of both disease prevention and of basic body

building processes.
• Found in fresh fruits, berries, citrus fruits and green vegetables.
• Vitamin C is water-soluble vitamin.
WHAT IS THE BENEFIT OF VITAMIN C?

• Collagen Production.
• Immune system booster.
• Cancer Prevention.
• Diabetes Control.
• Gallbladder diseases prevention.
• Needing for healing wounds.
 WHAT IS OUR DOSAGE FORM?

• Chewing sugar-free gum.

• Composition: - Gelatin
- Glucose syrup
- Starch
- Flavoring (Extract fruits)
- Food coloring
- Ascorbic Acid.
• Available flavor: Grape, strawberry, orange
 RECOMMENDATIONS

• Infants and Children

• 0 - 6 months: 40 milligrams/day (mg/day) • 7 - 12 months: 50 mg/day
• 1 - 3 years: 15 mg/day
• 4 - 8 years: 25 mg/day
• 9 - 13 years: 45 mg/day
• Adolescents
• Girls 14 - 18 years: 65 mg/day • Boys 14 - 18 years: 75 mg/day
• Adults
• Men age 19 and older: 90 mg/day
• Women age 19 year and older: 75 mg/day
Women who are pregnant or breastfeeding and those who smoke need higher amounts.
 SIDE EFFECTS

• Abdominal cramps.
• Chest pain.
• Dental Erosion.
• Dizziness.
• Diarrhea.
• Headache.
 CAUTION

• Avoid high dose of Vitamin C.

• Pregnancy and breastfeeding.
• People with high blood pressure.
• People taking an antibiotics.
• Allergy or sensitivity.
 QUALITY ASSURANCE PROCESSES

 Documentation.
 Inspection and Validation.
 Holistic Approach.
 Written Standard Operating Procedures.
 PRECLINICAL AND CLINICAL TESTING

Preclinical Testing:
 Pharmacology
- Pharmacodynamics
- Pharmacokinetics
- Toxicology
- Indication

Clinical Testing:
Has not been done. The result of all testing must be provided to appropriate regulatory agencies
in order to obtain permission to begin the clinical testing.
 REGULATORY AFFAIRS

 Submitting documents needed to obtain marketing approval for a drug.

 Compiling dossiers for submission to authorities.
 PRODUCTION

 Process of Production.
- Starting materials.
- Active Pharmaceutical Ingredients
- Excipient (Chewing-gum Form)
- Primary Packaging through sterilization process.
- Secondary Packaging. (Has not been done)
 MARKETING AND SALES

Marketing and Sales:

- Product Planning
- Pricing
- Promoting
- Distributing Product.