Module 5
Pharmaceutics
Drug Delivery System, Manufacturing, Physical Pharmacy, Jurisprudence DRUG
oArticle intended for the use in diagnosis, mitigation, cure, treatment, or prevention of disease in man/animals
oArticle (other than food) intended to affect the structure of any function of the body of human beings or animals
oComponent which produces pharmacologic activity (Active Pharmaceutical Ingredient)
oTherapeutic moiety
EXCIPIENTS
oInactive ingredient present in DF
DOSAGE FORM
oFormulation containing a specific quantity of AI(s) in combination with one or more excipients
DRUG PRODUCT/MEDICINE
oFinal dosage form that contains the API, generally, but not necessarily, in association with other ingredients
DRUG DELIVERY SYSTEMS
oPhysical carriers used to deliver medications to specific areas
oMeans 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
Drug Delivery System Manufacturing
oThe complete set of activities to produce a drug that comprise production and QC from dispensing of materials tothe release for distribution of the finished product (AO 43 s1999)
Drug Establishment
oany organization or company involved in the manuf, import, packaging and/or distribution ofdrugs or medicines (AO 56 s1989)
Manufacturer Production of drug AO 56 s 1989 and IRR of RA9711
Trader Registered owner, subcontracts the manufacturer, may also engage in distribution and marketingAO 56 s 1989 and IRR of RA9711
Distributor/ Importer/ExporterImports/exports for own use or wholesale distribution to other establishmentsIRR of RA 9711
Distributor/ WholesalerProcures from a local establishment for local distribution on wholesale basisIRR of RA 9711
Intermediate Product
more stages ofproduction
Bulk Product
packaging
Finished Product
Good Manufacturing Practice (GMP)
oPart of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use (WHO, 2007)
oSystem 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 s1999)
oExamples: US FDA, WHO, EU, ASEAN, PIC/S
oPIC/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 Tight
-protects from extraneous solids and loss of article
-protects from contamination by extraneous liquid, solids, vapors, loss,
efflorescence, deliquesence, or evaporation
-impervious to air or any other gas
-holds a quantity intended for single dose; cannot beresealed
-permits withdrawal of successive portions
-holds a quantity of a drug intended for admin as a single dose promptly after opening
-contains more than a single unit ordose
Hermetic
Single -dose Multiple -dose Single -unit Multiple -unit Light -resistant Child -resistant -not for under 5 years old
-uses an indication or barrier to entry distinctive by design Tamper -evident Compliance packaging
PACKAGING MATERIALS
1. Glass –available in white flint (clear), amber, orcolored
I
II
III
NP–borosilicate
–treated SL (exempted form water attack test)
–soda lime
–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 to15°C
Controlled Room Temperature 2 to 8°C but allows excursions between 0 to15°C
Room Temperature 20 to 25°C (prevailing in working area)
Warm 30 to40°C
Excessive Heat Above 40°C
DryPlace Does not exceed 40% of average RH at Controlled RT
Pharmaceutics
Drug Delivery System, Manufacturing, Physical Pharmacy, Jurisprudence DRUG
oArticle intended for the use in diagnosis, mitigation, cure, treatment, or prevention of disease in man/animals
oArticle (other than food) intended to affect the structure of any function of the body of human beings or animals
oComponent which produces pharmacologic activity (Active Pharmaceutical Ingredient)
oTherapeutic moiety
EXCIPIENTS
oInactive ingredient present in DF
DOSAGE FORM
oFormulation containing a specific quantity of AI(s) in combination with one or more excipients
DRUG PRODUCT/MEDICINE
oFinal dosage form that contains the API, generally, but not necessarily, in association with other ingredients
DRUG DELIVERY SYSTEMS
oPhysical carriers used to deliver medications to specific areas
oMeans 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
Drug Delivery System Manufacturing
oThe complete set of activities to produce a drug that comprise production and QC from dispensing of materials tothe release for distribution of the finished product (AO 43 s1999)
Drug Establishment
oany organization or company involved in the manuf, import, packaging and/or distribution ofdrugs or medicines (AO 56 s1989)
Manufacturer Production of drug AO 56 s 1989 and IRR of RA9711
Trader Registered owner, subcontracts the manufacturer, may also engage in distribution and marketingAO 56 s 1989 and IRR of RA9711
Distributor/ Importer/ExporterImports/exports for own use or wholesale distribution to other establishmentsIRR of RA 9711
Distributor/ WholesalerProcures from a local establishment for local distribution on wholesale basisIRR of RA 9711
Intermediate Product
more stages ofproduction
Bulk Product
packaging
Finished Product
Good Manufacturing Practice (GMP)
oPart of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use (WHO, 2007)
oSystem 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 s1999)
oExamples: US FDA, WHO, EU, ASEAN, PIC/S
oPIC/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 Tight
-protects from extraneous solids and loss of article
-protects from contamination by extraneous liquid, solids, vapors, loss,
efflorescence, deliquesence, or evaporation
-impervious to air or any other gas
-holds a quantity intended for single dose; cannot beresealed
-permits withdrawal of successive portions
-holds a quantity of a drug intended for admin as a single dose promptly after opening
-contains more than a single unit ordose
Hermetic
Single -dose Multiple -dose Single -unit Multiple -unit Light -resistant Child -resistant -not for under 5 years old
-uses an indication or barrier to entry distinctive by design Tamper -evident Compliance packaging
PACKAGING MATERIALS
1. Glass –available in white flint (clear), amber, orcolored
I
II
III
NP–borosilicate
–treated SL (exempted form water attack test)
–soda lime
–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 to15°C
Controlled Room Temperature 2 to 8°C but allows excursions between 0 to15°C
Room Temperature 20 to 25°C (prevailing in working area)
Warm 30 to40°C
Excessive Heat Above 40°C
DryPlace Does not exceed 40% of average RH at Controlled RT
