Lecture Notes No. 5
Pharmaceutics
Drug Delivery System, Manufacturing,
Physical Pharmacy, Jurisprudence
,Drug Delivery System
DRUG
o Article intended for the use in diagnosis, mitigation, cure, treatment, or prevention of disease in man/animals
o Article (other than food) intended to affect the structure of any function of the body of human beings or animals
o Component which produces pharmacologic activity (Active Pharmaceutical Ingredient)
o Therapeutic moiety
EXCIPIENTS
o Inactive ingredient present in DF
DOSAGE FORM
o Formulation containing a specific quantity of AI(s) in combination with one or more excipients
DRUG PRODUCT/MEDICINE
o Final dosage form that contains the API, generally, but not necessarily, in association with other ingredients
DRUG DELIVERY SYSTEMS
o Physical carriers used to deliver medications to specific areas
o Means of administering drugs to the body in a safe, efficient, reproducible and convenient manner
USP Requirements
1. Natural products should be free from Salmonella spp.
2. Oral Solutions and suspensions should be free from E. coli.
3. Topical products must be free from Pseudomonas aeruginosa
4. Urethral, vaginal and rectal should be free from total microbial count
,o
Manufacturing
The complete set of activities to produce a drug that comprise production and QC from dispensing of materials to the
release for distribution of the finished product (AO 43 s 1999)
Drug Establishment
o any organization or company involved in the manuf, import, packaging and/or distribution of drugs or
medicines (AO 56 s 1989)
Manufacturer Production of drug AO 56 s 1989 and IRR of RA 9711
Trader Registered owner, subcontracts the manufacturer, may AO 56 s 1989 and IRR of RA 9711
also engage in distribution and marketing
Distributor/ Imports/exports for own use or wholesale distribution IRR of RA 9711
Importer/Exporter to other establishments
Distributor/ Procures from a local establishment for local IRR of RA 9711
Wholesaler distribution on wholesale basis
Intermediate Product
more stages of production
Bulk Product
packaging
Finished Product
Good Manufacturing Practice (GMP)
o Part of QA which ensures that products are consistently produced and controlled to the quality standards
appropriate to their intended use (WHO, 2007)
o System of QA aimed at ensuring that products are consistently manufactured to a quality appropriate for their
intended use and is concerned with both manuf and QC processes and procedures (AO 43 s 1999)
o Examples: US FDA, WHO, EU, ASEAN, PIC/S
o PIC/S GMP 2009 (Pharmaceutical Inspection Convention/Co-operation Scheme)
, PACKAGING (Primary or Secondary)
CONTAINER – holds the drug product and is or may be in direct contact with the drug product
Well-closed - protects from extraneous solids and loss of article
Tight - protects from contamination by extraneous liquid, solids, vapors, loss,
efflorescence, deliquesence, or evaporation
Hermetic - impervious to air or any other gas
Single-dose - holds a quantity intended for single dose; cannot be resealed
Multiple-dose - permits withdrawal of successive portions
Single-unit - holds a quantity of a drug intended for admin as a single dose promptly after opening
Multiple-unit - contains more than a single unit or dose
Light-resistant
Child-resistant - not for under 5 years old
Tamper-evident - uses an indication or barrier to entry distinctive by design
Compliance packaging
PACKAGING MATERIALS
1. Glass – available in white flint (clear), amber, or colored
I – borosilicate
II – treated SL (exempted form water attack test)
III – soda lime
NP – gen. SL
2. Plastic
Polyethylene, Polyvinyl chloride, Polypropylene, Polystyrene
Problems: Permeability, Leaching, Sorption, Light transmission, Alteration upon storage
3. Metal – tin, aluminum, aluminum alloy
4. Paper and Board – labels, cartons, layer boards
5. Films, foils and laminations – sachets, seals, strips, blisters
6. Rubber – closure for sterile products
STORAGE CONDITIONS
TERM CONDITION
Cold Not exceeding 8°C
Freezer -25 to -10°C
Refrigerator 2 to 8 °C
Cool 8 to 15°C
Controlled Room Temperature 2 to 8°C but allows excursions between 0 to 15°C
Room Temperature 20 to 25°C (prevailing in working area)
Warm 30 to 40°C
Excessive Heat Above 40°C
Dry Place Does not exceed 40% of average RH at Controlled RT
Pharmaceutics
Drug Delivery System, Manufacturing,
Physical Pharmacy, Jurisprudence
,Drug Delivery System
DRUG
o Article intended for the use in diagnosis, mitigation, cure, treatment, or prevention of disease in man/animals
o Article (other than food) intended to affect the structure of any function of the body of human beings or animals
o Component which produces pharmacologic activity (Active Pharmaceutical Ingredient)
o Therapeutic moiety
EXCIPIENTS
o Inactive ingredient present in DF
DOSAGE FORM
o Formulation containing a specific quantity of AI(s) in combination with one or more excipients
DRUG PRODUCT/MEDICINE
o Final dosage form that contains the API, generally, but not necessarily, in association with other ingredients
DRUG DELIVERY SYSTEMS
o Physical carriers used to deliver medications to specific areas
o Means of administering drugs to the body in a safe, efficient, reproducible and convenient manner
USP Requirements
1. Natural products should be free from Salmonella spp.
2. Oral Solutions and suspensions should be free from E. coli.
3. Topical products must be free from Pseudomonas aeruginosa
4. Urethral, vaginal and rectal should be free from total microbial count
,o
Manufacturing
The complete set of activities to produce a drug that comprise production and QC from dispensing of materials to the
release for distribution of the finished product (AO 43 s 1999)
Drug Establishment
o any organization or company involved in the manuf, import, packaging and/or distribution of drugs or
medicines (AO 56 s 1989)
Manufacturer Production of drug AO 56 s 1989 and IRR of RA 9711
Trader Registered owner, subcontracts the manufacturer, may AO 56 s 1989 and IRR of RA 9711
also engage in distribution and marketing
Distributor/ Imports/exports for own use or wholesale distribution IRR of RA 9711
Importer/Exporter to other establishments
Distributor/ Procures from a local establishment for local IRR of RA 9711
Wholesaler distribution on wholesale basis
Intermediate Product
more stages of production
Bulk Product
packaging
Finished Product
Good Manufacturing Practice (GMP)
o Part of QA which ensures that products are consistently produced and controlled to the quality standards
appropriate to their intended use (WHO, 2007)
o System of QA aimed at ensuring that products are consistently manufactured to a quality appropriate for their
intended use and is concerned with both manuf and QC processes and procedures (AO 43 s 1999)
o Examples: US FDA, WHO, EU, ASEAN, PIC/S
o PIC/S GMP 2009 (Pharmaceutical Inspection Convention/Co-operation Scheme)
, PACKAGING (Primary or Secondary)
CONTAINER – holds the drug product and is or may be in direct contact with the drug product
Well-closed - protects from extraneous solids and loss of article
Tight - protects from contamination by extraneous liquid, solids, vapors, loss,
efflorescence, deliquesence, or evaporation
Hermetic - impervious to air or any other gas
Single-dose - holds a quantity intended for single dose; cannot be resealed
Multiple-dose - permits withdrawal of successive portions
Single-unit - holds a quantity of a drug intended for admin as a single dose promptly after opening
Multiple-unit - contains more than a single unit or dose
Light-resistant
Child-resistant - not for under 5 years old
Tamper-evident - uses an indication or barrier to entry distinctive by design
Compliance packaging
PACKAGING MATERIALS
1. Glass – available in white flint (clear), amber, or colored
I – borosilicate
II – treated SL (exempted form water attack test)
III – soda lime
NP – gen. SL
2. Plastic
Polyethylene, Polyvinyl chloride, Polypropylene, Polystyrene
Problems: Permeability, Leaching, Sorption, Light transmission, Alteration upon storage
3. Metal – tin, aluminum, aluminum alloy
4. Paper and Board – labels, cartons, layer boards
5. Films, foils and laminations – sachets, seals, strips, blisters
6. Rubber – closure for sterile products
STORAGE CONDITIONS
TERM CONDITION
Cold Not exceeding 8°C
Freezer -25 to -10°C
Refrigerator 2 to 8 °C
Cool 8 to 15°C
Controlled Room Temperature 2 to 8°C but allows excursions between 0 to 15°C
Room Temperature 20 to 25°C (prevailing in working area)
Warm 30 to 40°C
Excessive Heat Above 40°C
Dry Place Does not exceed 40% of average RH at Controlled RT
