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It includes:

(i) All medicines for internal or external use of human beings or animals
and all substances intended to be used for or in the diagnosis,
treatment, mitigation or prevention of any disease or disorder in
human beings or animals, including preparations applied on human
body for the purpose of repelling insects like mosquitoes;
(ii) Such substances (other than food) intended to affect the structure or
any function of human body or intended to be used for the
destruction of vermin or insects which cause disease in human beings
or animals
(iii) All substances intended for use as components of a drug including
empty gelatin capsules; and
(iv) Such devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human
beings or animals, as may be specified from time to time by the
Central Government by notification in the Official Gazette, after
consultation with the Board
Natural
Plant source
Animal source
Marine source
Microbial source
Mineral source
Synthetic
Chemical
Genetically modified

The route of administration (ROA) that is
chosen may have a profound effect upon the
speed and efficiency with which the drug
acts.
Drug effect may be
Local; or
Systemic 2 types enteral and parenteral
Important
Info
Systemic
Local
Enteral
Parenteral
ROA
Appropriate administration route depends on:
The patients age
The patients condition, e.g. level of consciousness,
etc.
The properties of the drug (such as water or lipid
solubility, ionization, etc.)
The therapeutic objectives (for example, the
desirability of a rapid onset of action or the need for
long-term administration or restriction to a local site).
The dosage form in which the drug is available


May be therapeutic; or

The same drug may be
ineffective
harmful
sometimes even fatal

e.g. nitroglycerin
sublingual tablets
sublingual spray
ointment for transdermal application
intravenous solution for infusion

Giving a drug by mouth
is the most
common route of
administration but it is
also the most variable,
and requires the most
complicated pathway
to the tissues.
Convenient - can be self- administered, pain free,
easy to take
Absorption - takes place along the whole length
of the GI tract
Cheap - compared to most other parenteral
routes

Sometimes inefficient - only part of the drug may
be absorbed
First-pass effect - drugs absorbed orally are
initially transported to the liver via the portal vein
eg. Propranolol, lidocaine
Irritation to gastric mucosa - nausea and vomiting






Destruction of drugs by gastric acid and digestive
juices eg. Penicillin, proteins and peptides
Effect too slow for emergencies
Unpleasant taste of some drugs



Unable to use in unconscious patient

Buccal the
medicament is placed
between cheek and
the gums eg.
testosterone
Sublingual the
medicament is placed
under the tongue and
allowed to dissolve
eg. nitogycerine
Rapid absorption and higher blood levels due
to high vascularisation
No hepatic first pass metabolism
No GIT degradation of drugs
Presence of saliva facilitates both drug
dissolution and its subsequent permeation
Latest approach Buccal spray (translingual
delivery)
Eg. nitroglycerin
Important ROA for children and elderly

Suppositories
Enemas
Absorption is more rapid than oral
Bypasses hepatic first pass metabolism
Eg. Aspirin, paracetamol, theophylline,
barbiturates, bisacodyl
Limited surface area for absorption
Irritating suppository bases like PEG lead to
defecation and loss of drug
Fecal matter retards absorption
Patient non compliance

Dose forms for topical administration include:
Skin:
creams
ointments
lotions
gels
transdermal patches
disks

Eye or ear:
solutions
suspensions
ointments
Nose and lungs:
sprays and powders

Vagina:
tablets
creams
ointments
Urethra:
inserts
suppositories

Rectum:
creams
ointments
solutions
foams
Dose forms for topical administration include:
Skin is the largest organ in the body.
Weight 2 kg
Surface area 2 m
2
Effects can be local or systemic

Local
Systemic
Topically applied drugs meant to exert
systemic effects transdermal or
percutaneous
Beneficial for drugs having
low oral bioavailability
short half life
Patient compliance is very high
Eg. Of local drug delivery anti-acne, anti-
fungals, moisturizers
Eg. Of systemic drug delivery nicotine
patch, scopolamine patch, nitroglycerine
patch
Skin is a very good barrier
Absorption is very slow, thus cannot be used
for emergencies
Charged/ highly polar drugs cannot be given
by this route easily. To overcome this,
iontophoresis and phonophoresis have been
developed
Iontophoresis
electric current is
used



Phonophoresis
ultrasound is used
Mostly local for treatment of glaucoma,
infections etc
Effect of drugs depends upon:
pH of lachrymal fluid (tears)
Tear drainage
Rate of blinking
Occlusion into nasal cavity and hence GIT may
lead to systemic side effects
Volume of formulation that can be instilled is very
low 10 L

Patients head should be tilted back
After administration, the patient should place a
finger in the corner of the eye, next to the nose to
close the lacrimal gently
prevents loss of medication through tear duct
Patient should also keep the eyes closed for 1or 2
minutes after application

Eg. Of drugs
atropine, pilocarpine
For local effects mostly
Inconvenient for use
Can be used only with the aid of
a dropper
Eg. Of drugs
ciprofloxacin,
ofloxacin
Tilt head to side with ear
facing up
2 to 5 minutes
Cotton swabs placed in the ear
after administration of drops
will prevent excess medication
from dripping out of the ear
swabs will not reduce drug
absorption
Patients under 3
should have lobes
pulled down and
back.
Patients over 3
should should
have lobes pulled
up and back
Applied by:
drops (instillation)
sprays
aerosol (spray under pressure)

Used for:
relief of asthma or allergy symptoms
administration of flu vaccine

Metered-dose inhalers
(MDI) provide
medication with
compressed gas
deliver specific measured
dose with each activation

Some devices use a powder
or nonaerosolized spray for
inhalation instead of
compressed gas

Nebulizers create a mist
when a stream of air flows
over a liquid
commonly utilized for young
children or elderly patients
with asthma or lung disease

Large surface area of alveoli
Rich perfusion

Irritation
Damage to alveoli membrane


Local salbutamol, beclomethasone
Systemic - insulin
Uses
Disadvantages
Patient should:
tilt head back
insert dropper or spray or aerosol tip into
the nostril pointed toward the eyes
apply prescribed number of drops or sprays
in each nostril


Breathing should be through mouth to
avoid sniffing medication into the
sinuses

Can be used for systemic delivery of proteins
and peptides
Drug absorption is very rapid due to high
vasculature
Can be used to target drugs to brain

Most drugs can reach brain and show side
effects
Irritation to nasal mucosa
Difficulty in breathing
Disadvantage
Indicated for
bacterial or fungal infection
hormone replacement therapy

The patient is instructed to
use the medication for the
prescribed period to ensure
effective treatment

Avoidance of first pass metabolism
Controlled delivery is possible
Termination is possible


Vaginal secretions and microorganisms in the
vagina may metabolise the drug
Disadvantages
Parenteral administration is injection or infusion by
means of a needle or catheter inserted into the body
Parenteral forms deserve special attention
complexity
widespread use
potential for therapeutic benefit and danger
The term parenteral comes from Greek words
para, meaning outside
enteron, meaning the intestine
This route of administration bypasses the alimentary
canal
Parenteral preparations must be sterile
free of microorganisms

To ensure sterility, parenterals are prepared using
aseptic techniques
special clothing (gowns, masks, hair net, gloves)
laminar flow hoods placed in special rooms
IV route
directly into a vein

Prepared in hospitals and home healthcare
pharmacies
antibiotics
chemotherapy
nutrition
critical care medications
Intramuscular (IM) injections
into a muscle

Subcutaneous injections
under the skin

Intradermal (ID) injections
into the skin
The IV route is the fastest method for delivering
systemic drugs
preferred administration in an emergency situation
It can provide fluids, electrolytes, and nutrition
patients who cannot take food or have serious problems
with the GI tract
It provides higher concentration of drug to
bloodstream or tissues
advantageous in serious bacterial infection

IV infusion provides a continuous amount of
needed medication
without fluctuation in blood levels of other routes

infusion rate can be adjusted
to provide more or less medication as the situation
dictates
Traumatic injury from the insertion of needle
Potential for introducing:
toxic agents
microbes
pyrogens
Impossible to retrieve if adverse reaction occurs
injected directly into the body
Intramuscular (IM) and subcutaneous routes of
administration are convenient ways to deliver
medications
Compared with the IV route:
onset of response of the medication is slower
duration of action is much longer
Practical for use outside the hospital

Used for drugs which are not active orally
The injection site needs to be prepped
using alcohol wipe
Correct syringe, needle, and technique must be
used
Rotation of injection sites with long-term use
prevents scarring and other skin changes
can influence drug absorption
Not suitable for oily solutions & insoluble
substances
Drug administered cannot be withdrawn
Thrombophlebitis occurs at inj. Site
Lack of sterility may cause viral hepatitis or
AIDS
Increased risk of Adverse Drug Reactions
IV inj. Immediate effects
Valuable for emergency use
Suitable for large volume, irritating drugs
Permits titration of dose for protein & peptide
drugs
Bolus or very slow (as drip)
Must inject slowly as a rule
Complete bioavailability
Thiopentol, furosemide, diazoxide, sodium
nitroprusside, diazepam IV for quick effect
Rate of absorption slow, sustained
Vasoconstrictor retards absorption
Inj. of drug into subcutaneous site
Rapid effect from aqueous solution
Suitable for insoluble suspension & solid pellet
implantations
Only nonirritant drugs
Not suitable for large volume
Pain, necrosis
Absorption of solid pellets implanted under
the skin occurs slowly over weeks or
months,e.g Testosterone
Insulin, adrenaline, heparin, vaccines inj. SC
Deltoid, gluteus maximus
Rapid effect from aqueous solution
Slow, sustained effect from depot
preparation
Moderate volume, oily vehicles, irritant,
Penicillin's, amino glycosides, iron
Pain, Abscess
Direct inj. into artery
Localization of effect in particular tissue or
organ
Liver tumors, head & neck cancers
Diagnostics agents
Reserved route for experts
Drug inj. into layers of skin
Multiple puncture of epidermis
BCG, Small pox vaccination
Testing drug sensitivity- Penicillins
Blood Brain Barrier & Blood CSF Barrier slow
drug entry into CNS
Used when local and rapid effects of drugs on
the meninges or cerebrospinal axis desired
Spinal anesthesia
Acute CNS infections
Into spinal subarachnoid space
Direct intraventricular drug in brain tumors
Into the bone marrow

intravenous 30-60 seconds
intraosseous 30-60 seconds
endotracheal 2-3 minutes
inhalation 2-3 minutes
sublingual 3-5 minutes
intramuscular 10-20 minutes
subcutaneous 15-30 minutes
rectal 5-30 minutes
ingestion 30-90 minutes
transdermal (topical) variable (minutes to hours)

Route for administration
-Time until effect-

intravenous 30-60 seconds
intraosseous 30-60 seconds
endotracheal 2-3 minutes
inhalation 2-3 minutes
sublingual 3-5 minutes
intramuscular 10-20 minutes
subcutaneous 15-30 minutes
rectal 5-30 minutes
ingestion 30-90 minutes
transdermal (topical) variable (minutes to hours)

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