Ingredients in Formulated Products Flashcards
Importance of ingredient type and quantity
formulation purpose, consumer needs, functionality, safety/compliance, stability, supply/cost, environment impact, dosage/concentration
Types of finished formulations
pharmaceuticals, cosmetics, food and beverage, household, industrial, agricultural
Ingredient selection considerations
chem info, reactivity, blending, stability/shelf-life, safety, sources, environment, quality, packaging, labelling, trends, guidelines, product brief
Dosage forms
Oral, rectal, topical, parenteral, respiratory, nasal, eye, ear
Oral dosage
solutions, syrups, suspensions, emulsions, gels, powders, granules, capsules, tablets
Rectal dosage
suppositories, ointments, creams, powders, solutions
Topical dosage
ointment, cream, paste, lotion, gel, solutions, topical aerosols, foams, transdermal patches
Parenteral dosage
Avoiding digestive tract. injections, implants, irrigation, dialysis solutions
Respiratory dosage
Aerosols, inhalations, sprays, gases
Nasal dosage
solutions, inhalations
Eye dosage
solutions, ointments, creams
Ear dosage
solutions, suspensions, ointments, creams
Forms of finished formulations
Solid, liquid, semi-solid, aerosols and more
Active pharmaceutical ingredient
API. substance intended to furnish pharmacological activity or have direct effect in diagnosis, cure, mitigation, treatment or prevention or to restore, correct or modify physiological functions in humans
Excipient
other than active ingredient that’s been appropriately evaluated for safety and intentionally used in drug delivery
FPP
finished pharmaceutical product
Impurity or contaminant
Not known in the formulation
Resources for API and excipients
Pubchem, DrugBank, DailyMed, Merck Index Online, Pharmacopia
Pharmacopoeia
official book of standards for drugs prepared by any country. Specifies standards of identity, purity and strength. collection of monographs
Monograph
Book on a specialised topic.
Importance of pharmacopoeia - quality standards
standardisation, safety, efficacy, global reference, legal, R&D
Broad classification of pharmaceutical API’s
based on: therapeutic use, chemical structure, pharmacological activity, mechanism of action, physical state, route of administration, origin
Therapeutic use API
analgesics, antibiotics, antipyretics, antihypertensives, antidiabetics
Chemical structure API
small molecules and large molecules
Mechanism of action API
enzyme inhibitors, receptor modulators, ion channel blockers, DNA/RNA interacting agents
Physical state API
solid, liquid and gas
Route of administration API
oral, injectible, topical, inhalable
Origin API
synthetic, biological/biotechnological, natural