CEE 2. DDS

DDS/Manuf/QC

The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished products

manufacture, importation, repacking and/or distribution

DDS/Manuf/QC is any organization or company involved in the ______*_*__*,* __*_____*__*,* __*_____*__ *and/or* __*_____*__ of drugs or medicines

● Research & Development

● Production

● Quality Assurance

● Purchasing

● Sales & Marketing

● Engineering

● Medical & Regulatory Affairs

DEPARTMENTS IN A DRUG ESTABLISHMENT

Quality Control

It started with activities purpose is to control the quality of products or services by finding problems and defects.

True

Quality Control is the most basic level of quality.

False

Quality Assurance is the most basic level of quality.

Quality Assurance

Developed from the realization that quality could be improved by looking 'further up the line'.

True

Quality Assurance is aimed at

preventing nonconformities/defects

False

Quality Control is aimed at preventing nonconformities/defects

Quality Management

* management responsibility
* analysis and improvement

resources & measurement

Quality Management is the management of *&*________

realization

Quality Management is the management of the service or product '_____' processes (doing/making stuff),

Tablets

Solid preparations each containing a single dose of one or more active ingredients and obtained by compressing uniform volumes of particles

common

Tablets are the most _____ type of solid dosage form

TABLET HARDNESS TESTER

1\. Stokes-Monsanto

2\. Pfizer

3\. Schleuniger

4\. Strong-Cobb

5\. Erweka

Vernier Caliper

TABLET THICKNESS

Vernier Caliper Criteria: ____ standard thickness

Roche Friabilator

FRIABILITY TEST

>/= 650mg

Roche Friabilator Sample: - ______ (10 tabs)

Roche Friabilator Sample: ______ (20 tabs)

Basket Rack Assembly

DISINTEGRATION TEST

6

Basket Rack Assembly Sample: ___ tablets

30 mins; No palpable core

Plain tab (criteria) 

3 minutes

SL (criteria)

4 hours

Buccal (criteria)

2 hours

Enteric-coated (criteria)

None

Chewable (criteria)

Rotating basket

DISSOLUTION TEST: Type I

Paddle

DISSOLUTION TEST: Type II

Reciprocating cylinder 

DISSOLUTION TEST: Type III

flow through cell

DISSOLUTION TEST: Type IV

85-115%

CONTENT UNIFORMITY (For

CONTENT UNIFORMITY

For

WEIGHT VARIATION TEST 

For >/= 50 mg AI

1\. Free of defects

2\. Strong enough to withstand the mechanical stress

3\. Chemically and physically stable over time

4\. Capable of releasing medicinal agents in a predictable and reproducible manner

Characteristics of Ideal Tablet

Diluents

* Bulking agents
* Improve cohesion
* Permit direct comprehension
* Promote flow

Binders

Granulators promote cohesive compacts

Disintegrants

Drawing water into tablet, swelling, and causing the tablet to burst

Lubricants

Reduce friction

Glidants

Promote the flow during granulation

Anti-adherents

Reduce sticking on the faces of the walls and dies

Capping and Lamination

Sedation of top or bottom

Picking and Sticking

Removal of surface adhesion of tablet material to the die wall

Mottling

Unequal distribution

Pulvules

bullet-shaped capsules

Capsules

enclosed in Gelatin shell

\
* High Accuracy/precision and hermetically sealed
* Reduced dustiness in manufacturing process
* Reduced gastric irritancy

ADVANTAGE: Soft Gelatin Capsule (SGC)

* Rapid drug release
* Unique mixed fills possible
* Good barriers to atmospheric oxygen

ADVANTAGE: Hard Gelatin Capsule (HGC)

* Costly to produce


* Product manufacturer is contracted out to a limited number of specialty houses
* Intimate contact between the shell and contents hence stability is a concern
* Mixed fills not adaptable

DISADVANTAGE: Soft Gelatin Capsule (SGC)

* Not suitable for bulky materials and strongly hygroscopic drugs
* Maintenance of proper shell moisture content essential, therefore storage at 45-65% RH required
* Cross-linking can affect HGC

DISADVANTAGE: Hard Gelatin Capsule (HGC)

HARD

Shell manufacture and filling are separate process

Dry filled capsules

Hard capsules are also known as “___”

SOFT

Manufacture, filling and sealing in a single operation with plasticizer

Soft elastic capsule

Soft capsules are also known as “___”

Bloom/Gel Strength

a measure of cohesive strength of cross-linking that occurs between gelatin molecules and is proportional to the MW of the gelatin Higher the bloom strength

150-250 g

Bloom range

Iron Content

It is present in raw gelatin as well as water is used in mfg. excess qty. of iron can effect FD and C and react with organic compounds.

not more than 15 ppm.

Iron is used in the concentration of ___________

Suppository

Solid dosage forms which are designed to be inserted into body orifices where they will exert action

Rectal Suppository

cone or torpedo shaped weighing 1-2g

Vaginal Suppository

globular, cone or wedge shaped weighing 2-8g

Pessaries

Vaginal Suppositories are also known as “____”

glycero-gelatin or macrogol base

Vaginal Suppositories are made from ____

Urethral Suppository

thin pencil shaped and pointed at one end

4g and 100-150 mm

Male bougies

2g and 60-75mm

Female bougies

Nasal Suppository 

Thin pencil shaped with pointed ends

Ear cones

pencil shaped

Rectal Suppositories (purpose)

\
* To relieve constipation
* Irritation
* Itching
* Inflammation associated with hemorrhoids

* Contraceptives
* Antiseptic in female hygiene

Vaginal Suppositories (purpose)

\

Trichomonas vaginalis

Vaginal suppositories have specific agents to combat an invading pathogen (______)

Urethral Suppositories (purpose)

\
* Antibacterial
* Local Anesthetic preparative for a urethral examination

Monophasic

Liquid Dosage Forms are also called “_____”

* Ease of administration
* Greater bioavailability
* More economical

Advantage: Liquid Dosage Forms

* Bulky
* Less stable
* Not for insoluble compounds
* No uniformity of dosage

Disadvantage: Liquid Dosage Forms

* Purified Water, USP 
* WFI, USP


* SWFI, USP
* BWFI, USP
* Sterile Water for Inhalation
* Sterile Water for Irrigation

TYPES OF OFFICIAL WATERS

* Aromatic H2O 
* Douche 
* Enema 
* Gargle 
* Mouthwash 
* Juices 
* Nasal 
* Ophthalmic 
* Otic/Aural/ Ear Preparation 
* Irrigation

TYPES OF AQUEOUS SOLUTIONS

Syrups

conc sol'n of sugar

Honey

honey-based

Mucilage

dispersing gum in water

Collodion

pyroxylin + Ethyl ether & Ethanol (3:1)

Elixir

Sweetened hydroalcoholic solution

Spirits / Essences

Hydroalcoholic solution of volatile oil or aromatic substance

1. Prepared by Distillation
2. Simple Solution Method 
3. Chemical Reaction

METHOD OF PREPARATION OF SPIRITS

Liniments

Intended for external application to skin by rubbing

Aerosols

Pressurized dosage forms that, upon actuation, emit a fine dispersion of liquid and/or solid materials containing one or more active ingredients in a gaseous medium.

Tinctures

alcoholic or hydroalcoholic extracts

Fluid Extracts

100% tincture extracts

Suspensions

Heterogeneous mixture of a solid dispersed in a liquid

Emulsion

* Internal/dispersed/discontinuous phase
* External/dispersing medium/continuous phase

Fluorescence test

if an emulsion on exposure to ultraviolet radiations shows continuous fluorescence under microscope → w/o presence → o/w

Cobalt chloride test

when an emulsion is added to a dried filter paper soaked in cobalt chloride solution, it turns from blue to pink, indicating that the emulsion is o/w type

Pastes

Semi-solid preparation which contains a greater amount of solid as compared to ointments

Glycerogelatin

Composed of glycerine, gelatin, water and additional substance

Plasters

Adhesive masses spread upon a backing material usually fabric or paper

Packaging

An economical means of providing presentation, protection, identification/information, containment, convenience and compliance for a product during storage, carriage, display and use until such time as the product is used or administered

Containers

Holds the drug product and is or may be in direct contact with the drug product

Borosilicate

Type 1 Glass: “_____”

Type 1 Glass: “_____”