Oral Liquids -[Raw Materials, Adjuvants and Manufacturing Considerations]

Proverbs 16:3

Solution

Are liquid preparations that contain one or more substances dissolved in water

Solution

Are co-solvent mixtures of mutually miscible solvents.

Solution

Are homogenous one-phase system consisting of 2 or more components.

Solution

The most commonly used liquid dosage form.

Solution

Solute + Solvent = ____ ?

1. Oral solutions

2. Topical solutions

3. Ophthalmic solutions

4. Nasal and Otic solutions

5. Vaginal solutions

6. Rectal solutions

Solution As to its use [6]

• Aromatic waters

• Syrups

• Elixirs

• Spirits

• Tinctures and fluidextracts

• Douches, enemas, and gargles

• Liniments, collodions, and others

Solution As to composition [7]

General Formula for Solution

Co-solvent

[Common Components in Oral Liquids]

Are water-miscible organic solvents used to improve the solubility of poorly water-soluble drugs

Solubilizer

[Common Components in Oral Liquids]

Are surfactant with solubilizing ability (Solubilization)

Viscosity Enhancer

[Common Components in Oral Liquids]

Improves pourability and, to some extent, palatability

Buffer

[Common Components in Oral Liquids]

Controlling pH to maintain solubility and stability (Most common: pH 4–7)

Preservatives

[Common Components in Oral Liquids]

Prevent microbial growth

• Ethanol

• Sorbitol

• Glycerin

• Propylene Glycol (PEG)

• Polyethylene Glycol (PPG)

Example of Co-solvent [5]

Solubilizer

Tween is a _____ ?

• Sugar

• Polyvinylpyrrolidone (PVP)

• Cellulose derivatives

Example of Viscosity Enhancer [3]

• Citric acid

• Lactic acid

• Glutaric acid

Example of Buffer [3]

• Benzoic acid and its salts

• Parabens

• Thimerosal

• Chlorobutanol

• Benzyl alcohol

• Benzalkonium chloride

Example of Preservatives [6]

1. Preparation of formulation materials and equipment

2. Compounding

3. Storage and Aging

4. Filtration and Clarification

5. Filling and Packaging

General Steps In Manufacturing Solutions [5]

increase

[Factors Affecting Solubility]

Increase Temperature = ____ [increase / decrease] rate of solubility

increases

[Factors Affecting Solubility]

Decrease Particle Size = ____ [increase / decrease] rate of solubility

increases

[Factors Affecting Solubility]

Increase mixing/agitation = ____ [increase / decrease] rate of solubility

• soluble

• insoluble

[Factors Affecting Solubility]

"Like dissolves like"

• polar + polar = _____ [soluble/insoluble]

• non polar + polar= ____ [soluble/insoluble]

• Mixing tanks equipped with agitators

• Measuring and weighing devices

• Filtration/Clarification System

Manufacturing Equipments For Liquids [3]

Mixing tanks equipped with agitators

[Manufacturing Equipment for Liquids]

• Constructed of polished stainless steel and jacketed to allow for heating and cooling of the contents (using steam for heat).

Agitator

_______ - mixes the product during storage.

• Mixers/compounding tanks

• Storage tanks

• Portable transport tanks.

Types of Agitator [3]

Nylon

[Examples of Filter Cloth Media]

_____-

• Superior type

• Unaffected by molds/fungi

Nylon

[Examples of Filter Cloth Media]

Can be resterilized by autoclaving

Nylon

[Examples of Filter Cloth Media]

Have negligible absorption properties.

Filter Cloth

[Examples of Filter Cloth Media]

For straining syrupy liquids

Stainless Wire Cloth

[Type of Filter Media]

For filtration processes

• Nylon

• Filter Cloth

• Stainless Wire Cloth

Examples of Filter Cloth Media [3]

Felt Cloth

[Example of Filter Media, non woven]

Fibrous mass free from bonding agents.

Felt Cloth

[Example of Filter Media, non woven]

Mechanically interlocked to yield pore diameters with controlled porosity.

Felt Cloth

[Example of Filter Media, non woven]

For gelatinous solutions

Bonded Fabrics

[Example of Filter Media, non woven]

Binded textile fabrics with resins, solvents, and plasticizers.

Bonded Fabrics

[Example of Filter Media, non woven]

Not widely used due to interaction with additives

Kraft Paper

[Example of Filter Media, non woven]

inexpensive

Kraft Paper

[Example of Filter Media, non woven]

Used as a pharmaceutical standard.

Kraft Paper

[Example of Filter Media, non woven]

____-

• Have Controlled porosity

• Limited absorption capacity

• Low cost

Membrane filter media

[Types of Filter Media]

Composition:

• Esters of cellulose

• Nylon, Teflon, PVC, silver

• Porosity of 0.05–14 microns

Membrane filter media

[Types of Filter Media]

For sterile solutions

Membrane filter media

[Types of Filter Media]

Properties:

• 150 micron thickness

• Ideal for microfiltration

• Diatomite

• Infusorial earth

• Kieselgur

• Celite

• Cellulose

• Asbestos

Example of Filter Aids [6]

Filter Aids

[Types of Filter Media]

Form a highly porous and non-compressible cake which retains solids.

Filter Aids

[Types of Filter Media]

____-

• Forms a fine surface deposit which screens out all solids

• Prevents the clogging of supporting filter media.

Gravity Filtration

[Classification of Filtration]

Slow filtration process.

Vacuum Filtration

[Classification of Filtration]

Used for very large quantities.

Pressure Filtration

[Classification of Filtration]

Fast process

Pressure Filtration

[Classification of Filtration]

Used to achieve a highly polished product.

Parallel Filtration

[Classification of Filtration]

Uses one type of filter.

Series Filtration

[Classification of Filtration]

Uses more than one filter in sequence.

• Gravimetric method

• Volumetric Method

• Constant Level Method

Three Basic Liquid Filling Methods:

Gravimetric method

[Basic Liquid Filling Methods]

Limited to very large containers or highly viscous products

Gravimetric method

[Basic Liquid Filling Methods]

Also used for mobile and frothy solutions.

Volumetric Method

[Basic Liquid Filling Methods]

Involves pumping liquid at constant pressure

Volumetric Method

[Basic Liquid Filling Methods]

Used for ampules and syringes

reservoir

Volumetric Method has a _____ ?

Constant Level Method

[Basic Liquid Filling Methods]

Makes use of container height as the means of controlling the fill amount of each bottle.