DDS LECT FINALS - PT 2

● Alcohol, USP

● Glycerin, USP

● Propylene glycol, USP

● Purified Water, USP

PREPARATION SOLVENTS FOR LIQUID

ALCOHOL, USP (ETHYL ALCOHOL) (ETHANOL)

Most useful solvent in pharmacy thus recognized as a solvent and excipient in the formulation of oral pharmaceutical products.

ALCOHOL, USP (ETHYL ALCOHOL) (ETHANOL)

Used as primary solvent for many organic compounds

15.56°C 

Properties of Alcohol: standard temp. to assay an alcohol

94.9% - 96% ethanol v/v at 15.56°C and 99.5% (Dehydrated Alcohol)

Properties of Alcohol

Dehydrated Alcohol

Water-free

0.5%

Alcohol Content Limit for OTC Oral Products: Children under 6 yrs of age

5%

Alcohol Content Limit for OTC Oral Products: 6 to 12 yrs of age

10%

Alcohol Content Limit for OTC Oral Products: Over 12 yrs of age and adults

alcoholic beverages

Alcohol Content beyond 10% is for?

1. Diluted Alcohol, NF

2. Rubbing Alcohol

3. Isopropyl Alcohol

Alcohol Preparations Available

DILUTED ALCOHOL, NF

Mixture of Alcohol, USP and Purified Water, USP

49%

Concentration of Diluted Alcohol

DILUTED ALCOHOL, NF

Hydroalcoholic solvent in various pharmaceutical processes and preparations

RUBBING ALCOHOL

Alcohol rubbing compound

RUBBING ALCOHOL

Contains about 70% ethyl alcohol or isopropyl alcohol by volume and the remainder consisting of water, denaturants and stabilizers.

70%

how many percentage of ethyl alcohol is in a rubbing alcohol?

355 mg sucrose octa-acetate or 1.4 mg denatonium benzoate; bitter substances

Formulation of Rubbing Alcohol

Formula 23-H

Denaturant agent for Rubbing Alcohol

○ Acetone

○ Methyl isobutyl ketone

○ Ethyl

Composition of Rubbing Alcohol

RUBBING ALCOHOL

Discourage the illegal removal for use as a beverage of the alcoholic content.

RUBBING ALCOHOL

Impossible separation of ethyl alcohol from the denaturants with ordinary distillation apparatus.

GLYCERIN, USP (Glycerol)

● Clear syrupy liquid with a sweet taste

● Miscible with water and alcohol.

GLYCERIN, USP (Glycerol)

It is used as stabilizer and auxiliary solvent in conjunction with water and alcohol

Propylene Glycol, USP

● Viscous liquid

● Miscible with water and alcohol

Propylene Glycol, USP

It is used as a solvent and substitute for Glycerin in pharmaceutical formulations.

PURIFIED WATER, USP

Most commonly used solvent for drug solutions

a. Purified Water, USP

b. Water For Injection, USP

c. Bacteriostatic Water For Injection, USP

d. Sterile Water For Injection, USP

e. Sterile Water For Inhalation, USP

f. Sterile Water For Irrigation, USP

Types of Water

Purified Water

Used for the preparation of medicines that do not have to be sterile and apyrogenic

Highly Purified Water

Used for the preparation of medicines where water of high biological quality is needed, except where water for injections is required

Water for Injections

Used for medicines for parental administration. Must be pyrogen-free

Sterilized Water for Injections

Used for medicines for parental administration. Water has been sterilized by heart and is suitably packaged

Distillation Method

Ion-Exchange Method

Reverse Osmosis

Methods in Preparing Purified Water

Distillation Method

Uses: Distillation apparatus
Result: Distilled water

Ion-Exchange Method

Uses: Ion-exchange equipment

Result: Deionized water

Reverse Osmosis

Uses: Cross-flow or tangential flow membrane filtration

Result: Concentrates/Permeates

Uses: Distillation apparatus
Result: Distilled water

Uses and Result of Distillation Method

Uses: Ion-exchange equipment

Result: Deionized water

Uses and Result of Ion-Exchange Method

Uses: Cross-flow or tangential flow membrane filtration

Result: Concentrates/Permeates

Uses and Result of Reverse Osmosis

ION-EXCHANGE METHOD

Passes water through a column of cation and anion exchangers consisting of water-insoluble synthetic polymerized phenolic, carboxylic, amino or sulfonated resins.

Cations or acid exchangers

Anions or base exchange resins

Two types of resins

Anions or base exchange resins

type of resins which permit the removal of anions

Cations or acid exchangers

type of resins which permit the exchange of the cations in solution with hydrogen ion.

REVERSE OSMOSIS

Pressurized stream of water is passed parallel to the inner side of a filter membrane core.

Microfiltration

0.1 to 2 micrometers (bacteria)

Ultrafiltration

0.01 to 0.1 micrometers (virus)

Nano-filtration

0.001 to 0.01 micrometers (Org. compounds in the MW of 300-1000)

Reverse Osmosis

Less than 0.001 micrometers