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

inactive ingredient present in drug product

formulation containing a specific quantity of all, in combination with one or more excipients

final dosage form that contains the API, generally but not necessarily, in association with other ingredients

natural products should be free from

oral solutions and suspensions should be free from

topicl products must be free from

high solubility high permeability

low solubility high permeability

high solubility low permeability

low solubility low permebilty

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

part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use

imprevious to air or any other gas

document that specifies all the tests to be conducted on a product and/or appropriate references containing detail of procedure and expected result

finite number of objects selected from a batch

this should cover all characteristics that affect the proper performance, purity, safety, and stability of the product

step by step method on how to go abouut a job

capacity o drugs to remain within specifiction

excess medicaments in manufacturing unstable drugs

senior citizens act

expanded senior citizens act

expanded senior citizens act of 2010

rules and regulations to implement dispensing requirements under the genric act of 1988

rules and regulations to implements prescribing requirements under the generics act of 1988

components of the national drug policy, except

system of words to represent words

method of secret writing

confidential to one or few

an act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names

comprehensive dangerous drus act

dangerous drugs act

revised regulation for the licensing of drugs establishments and outlets

foods, drugs, and cosmetics drugs act

intelletual property code (june 6 1997)

license of prescriber

application of physical and chemical principles and laws in the pharmaceutical sciences

basic unit of matter

"expiration dating period" the period of time where 90% of the original concentration is left and 10% is already degraded

the period of time required for the amount or concentration of a drug to decrease by one-half or 50%.

-reaction is dependent on the squaed amount of drug remaining -no application in pharmaceutical dosage form

the rate of reactions dependent on the concentration of drug remaining -most drugs follow this reaction

- the drug concentration changes with respect to time at constant rate - the rate of reaction is independent of the concentration of the reactants - eg. Alcohol, aspirin, phenytoin

the way in which the concentration of the drug or reactant in a chemical reaction affects rate

- Velocity with which the reaction occurs - Depends on:  Reactant concentration  Temperature  pH  presence of solvents or additive

o Study of the rates of reactions and the mechanism by which these reactions occur o Application in pharmacy: stability and bioavailability of pharmaceutical products

phenomenon of lowering the melting point due to combinations of components (thymol-salol; camphor-menthol)

- Is the point where solid A, solid B and the liquid phase co-exist - 3-phases co-exist

phases of constant composition that separate when a mixture is prepared within the boundary of the 2-phase system

line from which a system separates into phases of constant composition; used to approximate the proportions of components A & B existing at a particular temperature

temperature beyond which every proportion of A & B will exist as 1-phase; maximum temperature to obtain a one phase system

area within the curve represents a two phase system; Any point beyond it is a single phase

 Aka Condensed system  System in which vapour phase is ignored and only the solid and/or liquid phases are considered

heat required t convert 1 mole of solid to liqid

heat required to convert 1 mole of solid to gas

heat required to convert 1 mole of liquid to gas

 Heat necessary for 1 mole of a gas, solid or liquid to change to another phase  Either gained or lost  NOTE: without latent heat, no phase transition

o Represents the states of matter that exist as temperature and pressure are varied. o It is a graphic way to summarize the conditions under which equilibria exist between the different states of matter. o Such a diagram also allows us to predict which phase of a substance is present at any given temperature and pressure.

𝑯𝑹 = 𝑽𝒐 𝑽𝒇 𝑯𝑹 = 𝒕𝒂𝒑𝒑𝒆𝒅 𝒃𝒖𝒍k

what formula is this

what formula is this

measure of total voids/ spaces

sieve number

2 tangets separated by the longest distance

distance that will bisect the particle into halves

diameter of the circle that will enclose the particles

study of small particles

o Characterized of having fixed shapes, nearly incompressible o Have strong intermolecular forces, very little kinetic energy o Their atoms vibrate in fixed positions about an equilibrium position, there is very little translationalmotion

geometric form of nacl

geometric form of urea

geometric form of iodoform

geometric form of iodine

geometric form of sucrose

gometric form of boric acid

a solid may exist in more than 1 crystalline form

 The molecules or atoms are arranged in repetitious three-dimensional lattice units  Solvates –aka “pseudopolymorphs”; crystals having solvent molecules  Types based on geometric forms

- A phenomenon in which a solid forms a gel more readily when gently shaken or otherwise sheared than when allowed to form the gel while the material is kept at rest - ⬆time, ⬆ɳ

- Breakdown of structure (shear-thinning) that does not reform immediately when stress is removed or reduced - Thixotropy is an isothermal and comparatively slow recovery (on standing of a material) of a consistency lost through shearing - ⬆time, ⬇ ɳ - Shows a hysteresis loop, that is, the curve obtained on increasing shear stress is not superimposable with that obtained on decreasing shear stress.

- Non-linear; “shear-thickening” - When stress is removed, a dilatant system returns to its original state of fluidity. - ⬇G, ⬆ ɳ - Eg: paint, starch paste

- Non-linear; “shear-thinning” - ⬆G (shear rate); ⬇ ɳ - Eg: catsup and toothpastes

- Simplest type of non-Newtonian behavior in which the curve is linear only at values ofF, beyond its yield value. - Yield value is the force that should be exceeded for a bingham body (plastic) to flow - Eg: gels, ointments, margarine

shear-dependent viscosity

 Has linear relationship between shear rate and shear stress  Constant viscosity with increasing rate  Eg: ethanol, water, acetone, glycerin, benzene

resistance to flow

o Scientific study of the deformation and flow properties of matter o Elasticity, fluidity (ɸ), viscosity (ɳ) and plasticity

shrinking, some lliquid is pressed out

liberation of oil or water due to deficient gel structure

taking up liquid with volume increase

taking up of liquid without volume increase

lilquid is removed, framework remains

coherent matrix is rich in liquid

consists of a condensed mass enclosing and interpenetrated by a liquid

formation of lumps

upward or downward movement of the internal phase

globules come together and fuse

total separation of two phases

globbules come together but do not fuse

 A system with particles being larger than 0.5 mcm  Emulsions and suspensions