MODULE 2

Question 1

SPECIAL TECHNIQUES

• Solubility is increased bt using a water-miscible solvent
• ethanol, propylene glycol, sorbitol, and glycerin

Answer 1

CO-SOLVENCY

Question 2

used to aid SOLUBILITY or POORLY-soluble drugs

Answer 2

SPECIAL TECHNIQUES

Question 3

SPECIAL TECHNIQUES

• A number of buffer systems can be used to achieve this technique
• Contributing toward overall isotonicity
• Preferential hydration of proteins and peptides
• Serving as bulking agents in lyophilized formulation

Answer 3

pH CONTROL

Question 4

SPECIAL TECHNIQUES

• It involves the addition/use of SOLUBILIZING AGENTS to increase the water-solubility of the drug in water
• it is also achieved through the addition of SURFACE ACTIVE AGENTS to form colloidal aggregates known as micelles

Answer 4

SOLUBILIZATION

Question 5

SPECIAL TECHNIQUES

• EDTA and citric acid
• Calcium ++ EDTA

Answer 5

COMPLEXATION

Question 6

SPECIAL TECHNIQUES

COMPLEXATION:
* a chelating agent that may exhibit microbial growth

Answer 6

CALCIUM++ EDTA

Question 7

SPECIAL TECHNIQUES

• addition of additives consisting of fairly high concentrations of ALKALI metal salts of vairous organic acid
• uses NON-micelle forming substances
• use of HYDROTROPES

Answer 7

HYDROTROPY

Question 8

SPECIAL TECHNIQUES

• conversion of POORLY water-soluble drugs to its water-soluble DERIVATIVES
• the MOST COMMONLY EMPLOYED technique for the pure form of drugs converted to their corresponding water-soluble salt of ester forms

Answer 8

CHEMICAL MODIFICATION OF THE DRUG

Question 9

REQUIREMENT OF PHARMACEUTICAL ELEGANCE

Answer 9

harmony of TASTE, COLOR, ODOR, VISCOSITY

Question 10

FLAVORING AGENTS

METALLIC

Answer 10

Grape
Lemon
Lime

Question 11

FLAVORING AGENTS

SOUR

Answer 11

• Citrus fruits
• Raspberry
• Root beer

Question 12

FLAVORING AGENTS

SALTY

Answer 12

• Apricot
• Butterscotch
• Vanilla
• Peppermint
• Licorice
• Peach
• Maple Sugar
• Mixed Citrus
• Wintergreen

Question 13

FLAVORING AGENTS

BITTER

Answer 13

• Chocolate
• Coffee
• Anise
• Grapefruit
• Cherry
• Walnut
• Mint
• Passionfruit

Question 14

• Substances which PREVENT BACTERIAL and FUNGAL growth in liquid formulations

Answer 14

PRESERVATIVES

Question 15

Sometimes desired to serve as:
○ Adjunct to palatability
○ To improve drainage (pourability)

Answer 15

VISCOSITY-BUILDING AGENTS

Question 16

EQUIPMENT recommended

Answer 16

FULLY SANITIZABLE STAINLESS STEEL 314

Question 17

• It is a unit operation in which mixtures of liquids and solids, slurry or feed is forced through a POROUS MEDIUM, in which solids FORM A CAKE ON THE SURFACE and the clear liquid is obtained
• The usual objective of filtration or clarification is to produce a sparkling liquid free from turbidity, precipitates, colloidal hazes or insoluble liquid droplets

Answer 17

FILTRATION SYSTEM

Question 18

FILTER MEDIA

• Nylon
• Cotton Fabric
• Stainless Steel Wire Cloth

Answer 18

Filter Cloth, Woven

Question 19

FILTER MEDIA

• Felt cloth
• Bonded Fabrics
• Kraft paper
• Porous stainless steel filter

Answer 19

NON WOVEN

Question 20

FILTER MEDIA

• Cellulose membrane filter

Answer 20

Membrane filter media

Question 21

FILTER MEDIA

• Diatomite
• Asbestos
• Cellulose fiber

Answer 21

FILTER AIDS

Question 22

BASIC FILLING METHODS

Answer 22

Gravimetric
Volumetric
Constant Level

Question 23

BASIC FILLING METHOD

• Limited to VERY LARGE CONTAINERS and/or HIGHLY VISCOUS liquid products
• When large quantities of liquid materials are handled, it is more convenient and accurate to adapt this method of filling
• For this reason, all liquid components of the cited formula are expressed in units of both volume and weight

Answer 23

GRAVIMETRIC

Question 24

BASIC FILLING METHOD

• Accomplished by pumping the liquid, at constant pressure, through the orifice of constant diameter and size, for a predetermined period of time

Answer 24

VOLUMETRIC

Question 25

# **BASIC FILLING METHOD** * Makes use of **container HEIGHT** as the means of **controlling the fill amount** of each bottle * The fill amount varies by adjusting the height to which the container is filled * Any dimensional variations in the container which results to comparable variations in the net fill per unit

Answer 25

CONSTANT LEVEL METHOD

Question 27

# **PHARMACEUTICAL SUSPENSIONS** * **EXTERNAL** phase or **DISPERSION** system

Answer 27

CONTINUOUS PHASE

Question 28

# **PHARMACEUTICAL SUSPENSIONS** * **INTERNAL** phase or **DISPERSED** system

Answer 28

DISCONTINUOUS phase

Question 29

# **TYPES OF SUSPENSION SYSTEMS** * Also called ***Coagulated System*** and ***Colloidally Unstable System***. * Particles appear like **tufts of wool**, with **loose fibrous structure**.

Answer 29

FLOCCULATED SYSTEM

Question 30

# **TYPES OF SUSPENSION SYSTEMS** If a suspension is to be made by **DISPERSION METHOD**, it is **best** to achieve particle size reduction by:

Answer 30

MICRONIZATION METHOD SPRAY-DRYING METHOD

Question 31

# **PARTICLE SIZE REDUCTION** * Using **JET MILL** * The particles are subjected in a **TURBULENT AIR CHAMBER**. * Where powders c**ollide with each other** and fracture, obtaining particles with sizes **5 microns and below**.

Answer 31

MICRONIZATION METHOD

Question 32

# **PARTICLE SIZE REDUCTION** Produces finely divided particles by **SPRAYING A MIST** of liquid thru a **HEATED CHAMBER**, **drying immediately** and collecting the dried powders in a clean receptacle.

Answer 32

SPRAY-DRYING METHOD

Question 33

# **Closed-Cycle Design Type of Filling Spray-Dried Powders** * A **SUPERSATURATED SOLUTION** is formed and **quickly cooled** with **RAPID STIRRING**. * This causes the formation of nuclei, so that the crystals will **NOT GROW TOO LARGE**.

Answer 33

CRYSTALLIZATION / PRECIPITATION METHOD

Question 34

# **Closed-Cycle Design Type of Filling Spray-Dried Powders** * It is accomplished by using a **HOMOGENIZER** or **COLLOID MILL** to produce particle size of **less than 1 micron**.

Answer 34

HOMOGENIZATION METHOD

Question 35

* A **HETEROGENOUS** SYSTEM OF **2 IMMISCIBLE LIQUIDS**. * Generally, one of the liquids is a type of **oil or lipid** (HIGH GRADE MINERAL OIL) or a variety of animal or vegetable oil and the other liquid is water * It may be an **O/W** type or **W/O** type.

Answer 35

EMULSION

Question 36

# **MAJOR FACTORS IN THE PREPARATION OF EMULSION** * **Splitting** of emulsion into **TINY DROPLETS**.

Answer 36

DEGREE OF SHEAR

Question 37

# **MAJOR FACTORS IN THE PREPARATION OF EMULSION** * **AGITATION** required to the given **dispersion of droplets**.

Answer 37

TURBULENCE

Question 38

# **EQUIPMENT USED IN THE PREPARATION OF EMULSIONS** * Emulsions are **stirred** by means of **various impellers** mounted on shafts, which are placed directly into the system to be emulsified. * The **degree of agitation** is **controlled** by the **speed** of the **impeller system**. * This equipment is ideal for **SLOW MIXING** of finished emulsions, which have been prepared by melting the waxes.

Answer 38

MECHANICAL STIRRERS

Question 39

# **EQUIPMENT USED IN THE PREPARATION OF EMULSIONS** It is used to **produce FINE DROPLETS**, by: ■ First **compressing** the liquid, with **high pressure** ■ Escape of liquid radically past a **flat disc**, held by a **strong spring (rotor-stator) mechanism.** ■ The **high shearing stress** produced at pressures ranging from **500 to 1000 PSI** can **produce extremely fine droplets**, depending on the viscosity and interfacial tension of the system.

Answer 39

HOMOGENIZER

Question 40

# **EQUIPMENT USED IN THE PREPARATION OF EMULSIONS** * The use of this equipment will produce **EXTREMELY FINE particles** for moderately viscous emulsions. * This equipment is **NOT AVAILABLE** for commercial scale.

Answer 40

ULTRASONIFIER / ULTRASONICATOR

Question 41

# **EMULSION STABILITY METHODS OF EVALUATION** * The rate and extent is observed by **allowing** an emulsion **to stand in the container** (for a given period of time). * The **volume** of the **separated phases** are measured. * Such changes may be due to either **Creaming**, **Sedimentation** or **Coalescence**.

Answer 41

PHASE SEPARATION / SUBSIDENCE

Question 42

# **EMULSION STABILITY METHODS OF EVALUATION** * By **MICROSCOPIC examination**, the diameter of the droplets / particles could be measured. * Over a period of time particles are seen to **INCREASE** in size. * To remedy this, a **higher concentration of emulsifier** is **added**, to produce smaller droplet / particle size and to stabilize the product.

Answer 42

PARTICLE / DROPLET SIZE ANALYSIS

Question 43

# **EMULSION STABILITY METHODS OF EVALUATION** INFLUENCE OF TEMPERATURE: * To place the emulsion in a **600C oven** for a number of **hours**, remove then **transfer to a REFRIGERATOR** temperature. * **Continued** emulsion stability studies for a **few more weeks at 600C**, will be the basis that the emulsion **will be stable** for the **next two (2) years**.

Answer 43

METHOD A ACCELERATED STUDIES

Question 44

# **EMULSION STABILITY METHODS OF EVALUATION** INFLUENCE OF TEMPERATURE: * Perform **Long Term /Real Time** Stability Studies at **DIFFERENT CLIMATIC ZONES** for * Prediction of the **appropriate storage conditions** * **Projected shelf life** of the product.

Answer 44

METHOD B REAL TIME STUDIES