mod5

98問 • 1年前

問題一覧

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

drug

inactive ingredient present in drug product

excipients

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

dosage form

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

drug product/ medicine

natural products should be free from

samonella spp

oral solutions and suspensions should be free from

e. coli

topicl products must be free from

p. aeruginosa

high solubility high permeability

class 1

low solubility high permeability

class 2

high solubility low permeability

class 3

low solubility low permebilty

class 4

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

manufacturing

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

GMP

imprevious to air or any other gas

hermetic

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

monograph

finite number of objects selected from a batch

sample

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

finished product specification

step by step method on how to go abouut a job

SOP

capacity o drugs to remain within specifiction

stability

excess medicaments in manufacturing unstable drugs

overage

senior citizens act

ra 7432

expanded senior citizens act

ra 9257

expanded senior citizens act of 2010

ra 9994

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

ao 63 of 1989

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

ao 62 of 1989

components of the national drug policy, except

nota

system of words to represent words

code

method of secret writing

cipher

confidential to one or few

secret keys

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

ra 6675

comprehensive dangerous drus act

ra 9165

dangerous drugs act

ra 6425

revised regulation for the licensing of drugs establishments and outlets

ao 56 of 1989

foods, drugs, and cosmetics drugs act

ra 5921

intelletual property code (june 6 1997)

ra 8293

license of prescriber

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

physical pharmacy

basic unit of matter

atom

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

shelf life

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

half life

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

second order

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

first order

- 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

zero order

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

order of reacion

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

aota

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

chemical kinetics

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

eutexia

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

eutectic point

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

conjugate phase

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

tie line

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

critical solution temperature

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

binodal curve

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

two component system

heat required t convert 1 mole of solid to liqid

molar heat of fusion

heat required to convert 1 mole of solid to gas

molar heat ofsublimation

heat required to convert 1 mole of liquid to gas

molar heat of vaporzation

 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

aota

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.

phase diagram

𝑯𝑹 = 𝑽𝒐 𝑽𝒇 𝑯𝑹 = 𝒕𝒂𝒑𝒑𝒆𝒅 𝒃𝒖𝒍k

hausner's

what formula is this

carr's

what formula is this

pososity

measure of total voids/ spaces

porosity

sieve number

number of openings per linear inch

2 tangets separated by the longest distance

ferret diameter

distance that will bisect the particle into halves

martin diameter

diameter of the circle that will enclose the particles

projected area of the circle

study of small particles

micrometrics

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

solid

geometric form of nacl

cubic

geometric form of urea

tetragonal

geometric form of iodoform

hexagonal

geometric form of iodine

rhombic

geometric form of sucrose

monoclinic

gometric form of boric acid

triclinic

a solid may exist in more than 1 crystalline form

polymorphysm

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

crystalline

- 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

rheopexy

- 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.

thixotropy

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

dilatant

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

pseudoplastic

- 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

plastic

shear-dependent viscosity

non newtonian flow

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

newtonian flow

resistance to flow

viscosity

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

rheology

shrinking, some lliquid is pressed out

syneresis

liberation of oil or water due to deficient gel structure

bleeding

taking up liquid with volume increase

swelling

taking up of liquid without volume increase

inhibition

lilquid is removed, framework remains

xerogel

coherent matrix is rich in liquid

jelly

consists of a condensed mass enclosing and interpenetrated by a liquid

ged

formation of lumps

flocculation

upward or downward movement of the internal phase

creaming

globules come together and fuse

coalescence

total separation of two phases

cracking

globbules come together but do not fuse

aggregation/ agglomeration

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

coarse dispersion

gastro

Hannah Angelique Losaria · 100問 · 2年前

gastro