MECHANIS ATP GRADIENT CARRIER REMARKS

M
PASSIVE X HI->LOW X FICK’S LAW
DIFFUSION
FACILITATE X HI->LOW ✓ COMPETITIVE
D INHIBITION
TRANSPORT
ACTIVE ✓ LOW- ✓ COMPETITIVE
DIFFUSION >HIGH INHIBITION
MECHANIS ATP GRADIENT CARRIER REMARKS
M
PASSIVE ? ? ? ?
DIFFUSION
FACILITATED ? ? ? ?
TRANSPORT
ACTIVE ? ? ? ?
DIFFUSION
4. COVECTIVE TRANSPORT
5. ION-PAIR TRANSPORT
6. VESICULAR TRANSPORT
LOCAL vs SYSTEMIC
Intravascular vs
Extravascular
Parenteral vs Enteral

Are all parenteral products administered

via INTRAVASULAR route?
 PARENTERAL
 Intravenous
 Intraarterial
 Intracardiac
 Intramuscular
 Subcutaneous
 Intraarticular
 Intradermal/Intracutaneous
 Intrathecal
 ENTERAL
 Buccal
 Sublingual
 Peroral/oral
 Rectal
 ENTERAL
 Intranasal
 Inhalational
 SKIN
 Transdermal/percutaneous
 Topical
 MISCELLANEOUS
 Ophthalmic
 Otic
 Urethral
 Vaginal
SOLUBILITY DISSOLUTION
 EXTENT to which a drug  RATE to which a drug
dissolves dissolves
 maximum amount of
solute dissolved in a
solvent at equilibrium
 Permeability Solubility
CLASS I ? ?
CLASS II ? ?
CLASS III ? ?
CLASS IV ? ?

BIOAVAILABILITY?
BIOEQUIVALENCE?
BIOWAIVERS?
Apparatus I Apparatus V
Apparatus II Apparatus VI
Apparatus III Apparatus VII
Apparatus IV
The trade name of the drug?
The name used by organic chemists to
indicate the chemical structure of the
drug ?
 The established, nonproprietary, or
common name of the active drug in a
drug product (eg, acetaminophen).
The process of dispensing a different brand or an
unbranded drug product in place of the prescribed drug
product.
SAME
(1) API
(2) Dosage Form
(3) Strength
(4) Mode of administration
(1) Pharmaceutical Equivalents
(2) Approved as Safe and Effective
(3) Adequately Labeled
(4) cGMP Manufactured
(5) Bioequivalent
(1) Different Chemical Form of the API
(2) Different Dosage From
(3) Different in Strength
DIFFERENT
(1) API
SAME
(1) Therapeutic effect (Indication)
The process of dispensing a pharmaceutical alternative for
the prescribed drug product.
The process of dispensing a therapeutic alternative in place
of the prescribed drug product.
Application needed for Generic Drugs
Application needed for Innovator Drugs
refers to the Finished dosage form API w/ or w/o
refers to API
The process of dispensing a different brand or an
unbranded drug product in place of the prescribed drug
product.
SAME
(1) API
(2) Dosage Form
(3) Strength
(4) Mode of administration
(1) Pharmaceutical Equivalents
(2) Approved as Safe and Effective
(3) Adequately Labeled
(4) cGMP Manufactured
(5) Bioequivalent
(1) Different Chemical Form of the API
(2) Different Dosage From
(3) Different in Strength
DIFFERENT
(1) API
SAME
(1) Therapeutic effect (Indication)
The process of dispensing a pharmaceutical alternative for
the prescribed drug product.
The process of dispensing a therapeutic alternative in place
of the prescribed drug product.
Application needed for Generic Drugs
Application needed for Innovator Drugs
Physical property that measures the ratio of the solubility of
the drug in the oil phase and in aqueous phase.
A 25 y/o patient is taking Aspirin (pKa=3.5).
Determine the percentage of ionization of
drug at the stomach (pH=1).
A 25 y/o patient is taking Aspirin (pKa=3.5).
Determine the percentage of ionization of
drug at the intestine (pH=6).
A 25 y/o patient is taking Salicylic Acid
(pKa=3). Determine the percentage of
ionization of drug at the stomach (pH=1).
A 25 y/o patient is taking Salicylic Acid
(pKa=3). Determine the percentage of
ionization of drug at the intestine (pH=6).
Arrangement of a drug substance in various crystal forms or
polymorphs
• Amorphous
• Solvates/Hydrates
• Desolvated Solvates
Is a type of molecule that has a non-superimposable mirror
image
The process where the drug molecule combines with the
receptor molecule
The HIGHER the particle size the HIGHER the surface area
the FASTER the dissolution rate
Physical property that measures the ratio of the solubility of
the drug in the oil phase and in aqueous phase.
Aspirin is ionized in the stomach
Arrangement of a drug substance in various crystal forms or
polymorphs
Noncrystalline form of polymorphism
Is a type of molecule that has a non-superimposable mirror
image
The process where the drug molecule combines with the
receptor molecule
Added to a formulation to provide certain functional
properties to the drug and dosage form.
EXCIPIENT PROPERTY IN DOSAGE
FORM
Lactose Diluent
Dibasic Calcium Phosphate Diluent
Starch Diluent, Disintegrant
Microcrystalline Cellulose Diluent, Disintegrant
EXCIPIENT PROPERTY IN DOSAGE
FORM
Magnesium stearate Lubricant
Stearic acid Lubricant
Hydrogenated vegetable oil Lubricant
EXCIPIENT PROPERTY IN DOSAGE
FORM
Sucrose (Solution) Granulating Agent
PVP (Solution) Granulating Agent
Methylcellulose Granulating Agent/ Tablet
Coating Agent
HPMC Tablet Coating Agent
EXCIPIENT PROPERTY IN DOSAGE
FORM
Titanium Dioxide Colorant
CAP Enteric coating agent
EXCIPIENT PROPERTY IN DOSAGE
FORM
Sodium CMC Suspending agent
Tragacanth Suspending agent
Sodium alginate Suspending agent
Xanthan gum Thixotropic suspending
agent
Veegum Thixotropic suspending
agent
EXCIPIENT PROPERTY IN DOSAGE
FORM
Sorbitol Sweetener
Sucrose Sweetener
Propylene glycol Solubilizing agent
Alcohol Solubilizing agent,
Preservative
Methyl and Propyl Parabens Preservative
EXCIPIENT PROPERTY IN DOSAGE
FORM
Polysorbates Surfactant
Sesame oil For emulsion vehicle
Corn oil For emulsion vehicle
Starch
Lactose
Magnesium Stearate
Methylcellulose
HPMC
Sucrose (Solution)
Dibasic Calcium Phosphate
Microcrystalline Cellulose
CAP
PVP (Solution)
PVP
Titanium Dioxide
Tragacanth
Veegum
Alcohol
Polysorbates
Corn oil
Methyl paraben
Sorbitol
Sodium Alginate
Liquid preparations which contain an
active ingredient or drug substance
dissolved in a suitable solvent or
mutually miscible solvent
Finely divided solid which are dispensed
uniformly in a liquid
Solid preparations in which the inert
substance or medicinal substance are
enclosed in a small shell of Gelatin
Most commonly known solid preparation
Solid dosage form prepared by molding
or compression
Products that alter the timing and/or the
rate of release of the drug substance
1. Extended-release drug products
 Allow 2 fold reduction in dose frequency vs immediate
release
2. Delayed-release drug products
 Release the drug other than promptly after administration
3. Targeted-release drug products
 Release drug near the intended physiologic site of action
Self-contained discrete dosage form, which
when applied to the intact skin, will deliver the
drug at a controlled rate to the systemic
circulation.
PERMEATION ENHANCERS
BACKING MEMBRANE
DRUG RESERVOIR/ POLYMER MATRIX
ADHESIVE