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The Dietary Role of

Excipients MARY A. MURRAY, PH.D.

SENIOR PRINCIPAL RESEARCH SCIENTIST –

AMWAY NUTRILITE HEALTH INSTITUTE AAPS ANNUAL MEETING, SAN DIEGO CA, NOVEMBER 05, 2014

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Presentation Outline

Introduction to Calories and Energy

Nutrient Categories

Regulatory View

Macronutrient Labeling Requirements for Dietary Supplements

Nutrient Value of Common and Specialty Excipients

Macronutrient Profile: Report Example for Botanical Supplement

Summary

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How much energy in this piece of

cake?

a. 350,000 calories

b. 350 food calories

c. 350 food Cal

d. 350 kcal

e. 1468 kilojoules (kJ)

Answer: All of the above

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Definitions: Calories and Energy

The small calorie or gram calorie (symbol: cal) is the approximate amount of energy needed to raise the temperature of one gram of water by one degree Celsius at a pressure of one atmosphere.

The large calorie, kilogram calorie, dietary calorie, nutritionist's calorie, nutritional calorie, Calorie (capital C) or food calorie (symbol: Cal) is approximately the amount of energy needed to raise the temperature of one kilogram of water by one degree Celsius.

The large Calorie is equal to 1000 small calories or one kilocalorie (symbol: kcal)

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Definitions: Calories and Energy

A joule (symbol J) the heat required to raise the

temperature of 1 g of water by 0.24 K

The kilojoule (kJ) is equal to one thousand (103) joules.

In nutritional contexts, the kilojoule (kJ) is the SI unit of

food energy. Labels in certain countries express energy

in kilojoules (kJ).

However, the calorie and kilocalorie are still in common

use for Nutrition and food energy

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Energy Conversion:

When referring to Nutrition:

1 Calorie =1 kcal = 4.18 kilojoule (kJ)

.

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Essential Nutrients

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RDI's and nomenclature established for the following vitamins

and minerals which are essential in human nutrition:

Vitamin A,

Vitamin C,

Calcium,

Iron,

Vitamin D

Vitamin E

Vitamin K,

Thiamin,

Riboflavin,

Niacin

Vitamin B6

Folate

VitaminB12

Biotin

Pantothenic acid,

5,000 International Units

60 milligrams

1,000 milligrams

18 milligrams

400 International Units

30 International Units

80 micrograms

1.5 milligrams

1.7 milligrams

20 milligrams

2.0 milligrams

400 micrograms,

6 micrograms

300 micrograms

10 milligrams

Phosphorus,

Iodine

Magnesium

Zinc,

Selenium,

Copper

Manganese

Chromium,

Molybdenum

Chloride,

Potassium

(optional)

1,000 milligrams

150 micrograms

400 milligrams

15 milligrams

70 micrograms,

2.0 milligrams

2.0 milligrams

120 micrograms

75 micrograms

3,400 milligrams

The following synonyms may be added in parentheses immediately following the

name of the nutrient or dietary component: Calories--Energy

Vitamin C--Ascorbic acid

Cite: 21CFR101.9

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Micronutrients (Vitamins)

There are thirteen known vitamins that fall into

two groups, those that are water-soluble and

those that are fat-soluble.

Water-soluble: B Vitamins (8 in all), Vitamin C

Fat-soluble: Vitamins A, D, E & K

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Minerals are classified as either Macrominerals

or Microminerals (Essential Trace Minerals)

Macrominerals:

Ca, Mg, P, Na, K, and Cl

Essential trace minerals (Microminerals)

chromium, copper, iodine, iron,

manganese, molybdenum, selenium, and

zinc

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Macronutrients: Provide Energy

Macronutrient Calories (Kilocalories)/ gm Kilojoules/ gm

Protein 4 16.7

Fat 9 37.7

Carbohydrate 4 16.7

Many commonly used excipients contribute

to the macronutrient content of Nutritional Supplements

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Nutrition Reporting for Dietary

Supplements

(Focus on Macronutrients)

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Regulatory View: Cite: 21CFR101.9 Nutrition Statements for Dietary Supplements

The term serving or serving size used ( instead of dose ) plus delivery

format

Example: - tablets, capsules, stick pack , chew

A statement of Calories per serving rounded to the nearest 5

Energy amounts less than 5 calories per serving may be expressed as

zero.

Energy value per serving may also be expressed in kilojoule units, added

in parentheses immediately following the statement of the caloric

content

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Caloric Content reported as

Carbohydrates Protein,and Fat

Total Fat to the nearest gram ( < 0.5 g may be expressed as zero)

Saturated Fat

Trans Fat

Polyunsaturated Fat (voluntary)

Monounsaturated Fat (voluntary)

Cholesterol to nearest 5 mg ( unless <2 mg and no fat

calories reported)

Sodium < 5 mg reported as zero

Potassium ( voluntary) < 5 mg reported as zero

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Caloric Content reported as

Carbohydrates Protein,and Fat (cont)

Total Carbohydrate to nearest gram ( < 0.5 g may be expressed as

zero)

Total Dietary Fiber (< 0.5 g may be expressed as zero )

Soluble Fiber ( voluntary) * 4 Cal per gram

Insoluble Fiber ( voluntary)

Sugars to nearest gram (< 0.5 grams may be expressed as zero)

Sugar Alcohols ( voluntary)

Other Carbohydrates ( voluntary)

Protein to nearest gram (< 0.5 grams may be expressed as zero)

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Nutrient Value of Common and

Specialty excipients

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Macro-mineral Source: (Filler)

Calcium Carbonate, USP

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Macro-mineral Source: (Filler)

Oyster Shell Calcium Carbonate

Composition

Chemical

Specification

Ground Oyster Shells

Calcium NLT 38.0%

Calcium

Carbonate

NLT 94.9%

Arsenic NMT 3.0 ppm*

Heavy Metals

(as Lead)

NMT 20 ppm*

Lead NMT 0.4 ppm

Mercury NMT 0.5 ppm*

cGMP: The product is manufactured under full

compliance with cGMP requirements under

21CFR 111

Source: Undersea oyster shell beds in

San Francisco Bay

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Mandatory Nutrient Information

Amount Per 100 g

Total Calories 396 Calories from total fat 0 Total fat (g) 0 Saturated fat (g) 0 Cholesterol (mg) 0 Sodium (mg) 0 Total carbohydrate (g) 99 Dietary fiber (g) 0 Sugars (g) 99 Protein (g) 0 Vitamin A (I.U.) 0 Vitamin C (mg) 0 Calcium (mg) 3 Iron (mg) 0

Optional Nutrient Information Amount Per 100 g

Thiamine (mg) 0 Riboflavin (mg) 0 Niacin (mg) 0 Potassium (mg) 7 Phosphorous (mg) 4 Magnesium (mg) 0

Lactose Anhydrous, NF

Provides Carbohydrates

as Sugar Values per 100 grams of product

Calories 378

Calories from Fat 0 g

Total Fat 0 g

Saturated Fat 0 g

Trans Fat 0 g

Monounsaturated Fat 0 g

Polyunsaturated Fat 0 g

Protein 0 g

Total Carbohydrate 94.5 g

Sugars 6 g

Dietary Fiber 0 g

Soluble Fiber 0 g

Insoluble Fiber 0 g

Sugar Alcohols 0 g

Other Carbohydrates 88.5 g

Calcium 16 mg

Iron 0 mg

Sodium 90 mg

Magnesium 6 mg

Potassium 5 mg

Phosphorus 8 mg

Maltodextrin, NF

Provides

Carbohydrates as

“Other Carbohydrates” and Some Sugar.

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Nutritional Data

Calories 0 Calories from fat 0

Total fat 0

Saturated fat 0

Cholesterol Amino acids Protein Carbohydrates

0

0

0 < 0.25%

Sugars Dietary fiber Vitamin A Vitamin C

< 100 ppm > 97% (dried substance) 0

0

Sodium Calcium Iron

< 300 ppm

< 50 ppm

< 10 ppm

Co-Processed Silicified Microcrystalline Cellulose, NF

Provides Dietary Fiber, (Primarily Insoluble)

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Nutritional Yeast (Specialty Filler)

Nutritional yeasts grown specially for their nutritional

value in a nutrient mixture of

molasses, then killed through

pasteurization and sterilization, dried and sold as powder

Valued for natural Vitamin B

and protein content

Often fortified with additional

nutrients added to the growth

media

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TYPICAL ANALYSIS Per 100g “As Is”

Calories 375-395 kcal Fat 4-6 g

Moisture 2-6 g Saturated 1-2 g

Protein 48-60 g Unsaturated 2-4 g

Ash 6-.8 g Monounsaturated 2-4 g

Carbohydrates 25-35 g Polyunsaturated <1 g

Complex 25-35 g Trans Fatty Acids 0 g

Sugars <1 g Cholesterol 0 mg

Dietary Fiber 20-24 g Iron 4-7 mg

Soluble 4-8 g Calcium 65-75 mg

Insoluble 16-22 g Sodium 30-34 mg

Vitamin A <10 ug

RE Potassium 1800-

2200

mg

Vitamin C 0 mg Phosphorous 1000-

1200

mg

Thiamin 10-16 mg Pyridoxine 30-50 mg

Niacin 45-65 mg

NE Folic Acid 2-5 mg

Riboflavin 2-8 mg Vitamin B12 <1 ucg

Yeast Provides: micronutrient, macronutrient, macro-

minerals, essential trace minerals, fiber

Yeast Provides: micronutrients, macronutrients,

macro-minerals, essential trace minerals, fiber

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Disintegrants Provide

Carbs, Fiber and Protein

Soy Polysaccharides: (Specialty Disintegrant)

derived from processing

de-hulled and defatted soybean flakes,

Disintegrant Dietary Value kcal/100g

Croscarmellose Sodium 89.5%

Dietary fiber (INSF)

0

Sodium Starch Glycolate > 83% carbohydrates 377

Soy Polysaccharides Protein 10.0% , 68.7%(INSF),

8.9%(SF), 77.6 %(TF)

80

Soybean- Glycine max

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Fat Source (Lubricant)

Stearic Acid (vegetable)

Calories 895/ 100g

Fat 99.4%

Saturated Fat 99.4%

Trans Fat none

Sodium 0

Carbohydrate 0

Dietary Fiber 0

Protein 0

Iron <1 PPM

Shea Butter, The Karite Tree

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Natural Colorants ( Specialty Excipient)

Anthocyanins- Nutritional value as antioxidants

Anthocyanins are flavonoids in fruits and vegetables that render them vivid red to blue.

Annatto- Annatto, a carotenoid, is extracted from the orange coloured outer coat surrounding the seeds of the shrub Bixa orellana. This plant is native to South America, India, East Africa, the Caribbean and Philippines.

Caramel-Caramel color is a naturally derived colorant that results from the process of caramelization, or the carefully controlled heating of carbohydrates. These sugars are cooked to produce a brown color

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Example- Finished Botanical

Supplement: Macronutrient

Calculations and Assay Report

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Excipient Contribution to the

Macronutrient Content of a Botanical

Supplement

Per tab Per Serving (3 tablets)

Estimated Calorie/Nutrition Contribution

4 Botanical extracts (Actives) 435 mg

Dextrose Monohydrate (Filler/Binder) 153 mg 0.429 g 1.7 Cal (total Sugars)

Microcrystalline Cellulose

(Filler/Binder)

133 mg 0.399 g 0.387 g fiber (INSF)

Hydroxypropyl Methylcellulose

(Coating)

5 mg 0.015 g .014 g fiber (SF)

( .056 Cal)

Corn Starch, Powdered, USP

(Glidant/Moisture protection)

44 mg 0.132 g 0.48 Cal (Carbohydrates)

Maltodextrin (carrier for botanical

extract)

23 mg 0.069 g 0.26 Cal (sugars/other carbs)

Cellulose Gum (Disintegrant)

(Na Croscarmellose)

13 mg 0.039 g 0.034 g fiber (INS)

Stearic Acid (Lubricant) 27 mg 0.081 g 0.725 Cal ( Saturated Fat)

3.22 Cal contributed by excipients: per 3 tab serving

(3.22 kcall)

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Ave per tab Per 3 tab Serving kcal Est. Excipient

Nutrient 2 test Lots test results estimate contribution

Protein g/tab 0.00 0.00

Carbs g/tab 0.73 2.20 8.80 0.48 kcal

Total Fat g/tab 0.03 0.09 0.81 0.725 kcal

Sat Fat mg/tab 8.25 24.75

MonoUnSat Fat g/tab 0.03 0.10

PolyUnSatFat mg/tab 0.35 1.05

Trans Fat mg/tab ND ND

Sugars mg/tab 135.00 405.00 ((1.62) 1.96 kcal

Cholesterol mg/tab 0.03 0.09

Sodium mg/tab 0.34 1.02

Sol Fiber g/tab 0.01 0.03 ((0.12) 0.056 kcal

Insoluble fiber g/tab 0.28 0.84

Total Fiber g/tab 0.29 0.86

Average Weight 843.37 mg per 3 tab 2530 mg

kcal/3 tab serving 10.00 kcal 9.61 kcal 3.221 kcal

Botanical Supplement

Macronutrient Report for Botanical Supplement per 3 Tablet Serving

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In Summary

Know your Calories – 1 Calorie =1 kcal = 4.18 kilojoule (kJ). Assume in nutrition,.. calorie or cal = 1kcal

Nutrition Labeling of Food :Code of Federal Regulations Title 21, Volume 2 [Revised April 1,2014]

Cite: 21CFR101.9

Nutrition Labeling requirements are stringent in the US and Globally For Dietary and related category supplements

Excipients have Nutritional Value – pay close attention to the specialty excipients.

Most often macronutrient value, but in some cases macromineral, trace mineral (micro-mineral) or micronutrients are contributed.

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Acknowledgements

Mr. Kevin Robinson, Principal Engineer , Amway/Nutrilite

Health Institute

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“ Excipients are a key determinant

of dosage form performance “

Thank you!