[DDS-LEC-SEMIS] P1 - LIQUID DOSAGE FORMS

• Solution

• Dispersed System

2 General Class of Liquid Dosage Forms:

• Emulsion

• Suspension

Dispersed System includes:

Solutions

These are liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents.

Solutions

Homogenous one-phase system consisting of two or more components.

Solutions

This is most commonly used in liquid dosage form.

Solute and Solvent

Simplest solution consists of two components:

• Oral solution

• Otic solution

• Ophthalmic solution

• Topical solution

What are the uses of solutions?

• Aqueous solution

• Non-aqueous solution

• Sterile solution

What are the compositions of solutions?

Moles and ions

Attractive forces between atoms lead to the formation of?

Temperature and Pressure

These two can also change how much solute dissolves.

Dipole-dipole (Van der Waals forces)

Intermolecular Forces:

Interaction where the negative pole of one molecule points towards the positive pole of the other.

Ion-dipole Interaction

Intermolecular Forces:

Results of an electrostatic interaction between a charged ion and a molecule that has a dipole.

Ion-dipole interaction

Intermolecular Forces:

It is an attractive force that is commonly found in solutions, especially ionic compounds dissolved in polar liquids.

Hydrogen Bonding

Intermolecular Forces:

Involves strongly electronegative atoms such as oxygen, nitrogen, and fluorine.

Attractive Forces

The molecules cohere.

Repulsive Forces

Prevents molecular interpenetration and distraction.

1. Minimal

2. Stable

When the attractive and repulsive forces are equal, the potential energy between two molecule is (1)___ and the system is most (2)___.

Solubility

State when the total amount of solute in the solution and excess particles reaches equilibrium.

Very Soluble

<1

Freely Soluble

1-10

Soluble

10-30

Sparingly Soluble

30-100

Slightly Soluble

100-1,000

Very Slightly Soluble

1,000-10,000

Practically insoluble or soluble

>10,000

Like dissolves like

A solvent having a chemical structure most similar to that intended solute which most likely to dissolve.

Alcohol, USP

Solvents for Liquid Preparations:

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

Ethyl alcohol and ethanol

Two Types of Alcohol, USP:

94.9%-96%

What is the percentage of ethanol v/v at 15.56 degrees celsius?

99.5%

What is the percentage of dehydrated alcohol?

Alcohol

This is the most useful solvent in pharmacy; primary solvent for organic compounds.

Dehydrated alcohol

Water-free alcohol.

Glycol and Glycerin

These two allows reduction of the amount of alcohol required.

0.5%

Alcohol content limit for OTC Oral Products intended for Children:

Children under 6 years of age

5%

Alcohol content limit for OTC Oral Products intended for Children:

6 to 12 years of age

10%

Alcohol content limit for OTC Oral Products intended for Children:

Over 12 years of age and adults

• Diluted alcohol, NF

• Rubbing alcohol

What are the 2 two alcohol tetrations?

Diluted alcohol, NF

Mixture of alcohol, USP and Purified Water, USP.

Diluted alcohol, NF

This alcohol is a hydroalcoholic solvent in various pharmaceutical processes and preparations.

49%

What is the concentration of diluted alcohol, NF?

Rubbing alcohol

This alcohol is volatile and flammable.

Reficient

Rubbing alcohol acts as a substance that reduce redness.

70%

How many percentage of ethyl alcohol or isopropyl alcohol does rubbing alcohol contain?

355mg

In 100mL rubbing alcohol it contains how many mg of sucrose octa-acetate?

1.4mg

In 100mL rubbing alcohol it contains how many mg of denatonium benzoate.

Formula 23-H

What is the denaturant agent?

• Acetone

• Methyl isobutyl ketone

• Ethyl alcohol

What are the compositions of Formula 23-H?

Glycerin, USP (Glycerol)

Comparable of alcohol however because of its viscosity, solute are slowly soluble in it unless rendered by less viscous (heating).

• It also has preservative qualities.

Glycerin, USP (Glycerol)

Solvents for Liquid Preparations:

• Clearly syrupy liquid with a sweet taste.

• Miscible with water and alcohol.

• Stabilizer

• Auxiliary solvent in conjunction with water and alcohol

Characteristics of Glycerin, USP:

Propylene glycol, USP

Solvents for Liquid Preparations:

• Viscous liquid

• Miscible with water and alcohol

Propylene glycol, USP

This is a solvent and a substitute for Glycerin in pharmaceutical formulations.

Purified Water, USP

Solvents for Liquid Preparations:

The most commonly used solvent for drug solutions.

Purified Water, USP

It has fewer solid impurities than ordinary drinking water.

• Distillation

• Ion exchange

• Reverse osmosis

Purified Water, NF is obtained by?

0.0001% residues

1mg of solid per 100mL of water residues:

Parenteral preparations

Purified water cannot be used in this type of preparation.

Purified Water

Different Types of Water (British Pharmacopoeia):

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

Highly Purified Water

Different Types of Water (British Pharmacopoeia):

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

Water for Injections

Different Types of Water (British Pharmacopoeia):

Used for medicines for parenteral administration.

• Must be pyrogen-free.

Sterilized Water for Injections

Different Types of Water (British Pharmacopoeia):

Used for medicines for parenteral administration.

• Water has been sterilized by heat and is suitably packaged.

Distillation Method

Methods in Preparing Purified Water:

Distillation Apparatus

Result: Distilled Water

Ion-exchange Method

Methods in Preparing Purified Water:

Ion-exchange equipment

Result: Deionized Water

Reverse Osmosis

Methods in Preparing Purified Water:

Cross-flow or tangential flow membrane filtration.

10%-20%

Distillation Process:

First portion aqueous, distillate about ___%, which must be discarded, because it contains foreign substances.

Decomposition

Last portion water remaining must also be discarded and must not be subjected to further distillation in dryness because it will result in?

Ion-Exchange Method

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

Cations and Anions

What are the 2 types of Resins?

Cations

Acid exchanges which permit the exchange of the ___ in solution with hydrogen ion.

Anions

Base exchange resins which permit the removal of?

Reverse Osmosis

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

Filtrate

This is the portion of purified water.

Permeate

This is the filtered portion (because it permeated the membrane).

Concentrate

It contains the concentrated contaminants rejected by the membrane.

Low concentration

Reverse osmosis is more concentrated in?

Microfiltration

Cross-flow membranes:

0.1 to 2 um (Bacteria)

Ultrafiltration

Cross-flow membranes:

0.01 to 0.1 um (Virus)

Nano-filtration

0.001 to 0.01 um (Organic Compounds in the MW of 300-1,000)

Reverse Osmosis

Cross-flow membranes:

Less than 0.001 um

Simple Solution

Preparation of Solutions:

Prepared by dissolving the solute in most of the solvent, mixing until dissolved then adding sufficient solvent to bring the solution up to the proper volume.

Chemical Reaction

Preparation of Solutions:

Prepared by reacting two or more solutes with each other in a suitable solvent.

Solution by Extraction

Preparation of Solutions:

Vegetable or animal origin are often extracted with suitable solvent.

Dry Mixture for Solution

Medicinal, agents with insufficient stability in aqueous solution are produced in a dry mixture for solution to be reconstituted.

• Drug

• Flavorant

• Colorant

• Buffers

Formulative components of Dry Mixture for Solution:

7-14 days

Once reconstituted dry mixture solution remains stable when stored in the refrigerator for a labeled period of how many days?

Oral Rehydration Solution

Given to replace or replenish the rapid fluid loss/dehydration associated with diarrhea.

• Sodium

• Potassium

• Bicarbonate Ions

The loss of fluid during diarrhea is accompanied by depletion of?

45 mEq

Typical ORS contains: (1,000mL):

Sodium

20 mEq

Typical ORS contains: (1,000mL):

Potassium

35 mEq

Typical ORS contains: (1,000mL):

Chlorides

30 mEq

Typical ORS contains: (1,000mL):

Citrate

25g

Typical ORS contains: (1,000mL):

Dextrose

Oral Colonic Lavage Solution

Used in preparation of the bowel for procedures such as COLONOSCOPY.

PEG-ES

Balanced solution if electrolytes with polyethylene glycol.

Osmotic Agent

Oral Colonic Lavage Solution acts as ___ in GIT and balanced electrolyte concentration.

4L or 4,000mL

What is the dose of Oral Colonic Lavage Solution