DDS LAB - PREP 13: Kaolin Suspension

Suspension

A liquid dosage form wherein suspensoids, or finely divided drug particles, are suspended in a vehicle wherein said particles only demonstrate a minimal degree of solubility.

Reasons for Suspension Preparation

• Unstable in solution but are stable in suspension

• For ease of swallowing

• Availability of range of doses in comparison to solid dosage forms

• Masking of undesirable taste of certain drugs

Kaolin or China Clay

• The active ingredient in this preparation

• A naturally-occurring layered silicate mineral

• Medicinally used as an emollient and to control diarrhea

Kaolin Suspension (Non-Official)

Official Title

Gastrointestinal Drug

Category

China Clay/Light Kaolin/White Bole/Kaolin-Pectin Suspension

Synonym/s

Adsorbent; For treatment of diarrhea and enteritis in cattle and horses; treatment of ulcerative colitis

Use/s

Official Definition

A soft, white or yellowish white powder or lumps with a distinct earthy or clay-like flavor. It darkens and takes on a strong clay-like smell when wet. (Non-official)

General Features

• Therapeutically Effective

• Physical and Chemical Stability of Components

• Appearance, Taste, and Odor

• Must settle down and can easily be redispersed upon shaking

• Particle size must remain constant when it is left standing

• Easily and evenly poured

Advantages

• Can be administered through multiple administration routes

• Useful in administering large amounts of solid that would be inconvenient in capsule form

• Fine particle size, ready dissolution upon administration

• Flexible adjustment of doses

Disadvantages

• Needs to be shaken before use for redispersion

• Prone to contamination; requires preservatives

• Prone to higher risk of instabilities

• Unpalatable taste in solution form is solved by using undissolved drug particles as oral suspension

Flocculated System

Characteristics

• Particles are Loose Aggregates

• High Sedimentation Rate

• Loosely Packed Particle

Advantages

• Can be easily redispersed

• Less prone to compaction and caking

Disadvantages

• Frequent shaking is required to redisperse particles

• Rapid setting hinders accurate dosage measurement

Deflocculated System

Characteristics

• Particles Exist as Separate Entities

• Low Sedimentation Rate is closely packed as the repulsive forces between particles increases

Advantages

• Does not require frequent shaking

• Can look more homogenous and uniform for longer periods

Disadvantages

• Prone to caking and compaction

• Redispersing sediment can be difficult

Kaolin

Active Ingredient

Glycerin

Wetting Agent

Humectant

• Helps water solubilize kaolin

• Increase in _____ will cause foam

Sodium carboxymethylcellulose

Suspending Agent

Monobasic Potassium Phosphate

Flocculating Agent

Sodium Benzoate

Preservative

Purified Water

Solvent

1:1

Ratio in Preparation A and B

• 0.1 g sodium carboxymethylcellulose : 3 mL water

2.61

Specific Gravity of Kaolin

1.59

Specific Gravity of Sodium methylcellulose

2.34

Specific Gravity of Monobasic Potassium Phosphate

1.44

Specific Gravity of Sodium Benzoate

White Liquid with Dispersed Particles

Acceptance Criteria:

Appearance

7.3

Acceptance Criteria:

pH

No Sedimentation and Caking Present

Acceptance Criteria:

Physical Instability

Amber Bottle

Packaging Container