finals Flashcards
may be prepared from any combination of solid,
liquid or gas, the three states of matter
Solutions
Liquid preparations that contain one or more soluble chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents
Solutions
Homogenous mixture that is prepared by dissolving a solid, liquid or gas in another liquid and represents a group of preparations in which the molecules of the solute or dissolved substance are dispersed
Solutions
TYPES OF SOLUTIONS
Solid Solution
Liquid Solution
Gaseous Solutions
the solvent is solid
the solvent is liquid
the solvent is gas
Solid Solution
Liquid Solution
Gaseous Solutions
SS - Solid in solid example
Cu + gold= 12 karat yellow gold
SS- Liquid in solid example
Hg dissolved in Ag = amalgam
SS- Gas in solid
air dissolved in soap = floating soap
LS- solid in liquid
salt in water
LS- ▪ Liquid in liquid
alcohol and water
LS- Gases in liquid
carbonated beverages
GS- Solid in gas
sulfur in air
GS- Liquid in gas
water vapor in air
GS- Gas in gas
oxygenated air
FACTORS AFFECTING THE “RATE” OF SOLUBILITY
Particle size
Agitation
Temperature
an increase in surface area to the solvent will _____ rate of solution. So the particle size should be reduced by_____ before it is dissolved
Increase
communition
increases the rate of solution by removing from the surface of the solute. The more concentrated solution around it the ___ concentrated the solvent.
less
FACTORS AFFECTING SOLUBILITY OF SOLUTE
Temperature
Molecular Structure
Effects of other substance
pH (weak acids, weak bases)
has the widest range of usefulness of all the solvents employed in pharmaceutical dispensing or manufacturing. It is a good solvent for most
inorganic and organic
Water
good solvent for many organic substances both natural and synthetic.
Alcohol USP, Ethyl Alcohol, Ethanol
Alcohol USP, Ethyl Alcohol, Ethanol limit for:
6 to 12 years old
12 years old and bove
Adult
0.5%
5%
10%
99.5% absolute alcohol is partially free from water
Dehydrated Alcohol
prepared by mixing equal volume of Alcohol USP and purified water
Diluted Alcohol NF
– contains about 70% of ethyl alcohol by volume the
remainder consists of water, denaturants with or without color additives and perfume oils and stabilizers
Alcohol, Rubbing
– clear syrupy liquid with sweet taste.
Glycerin USP (Glycerol)
It is miscible both with water and alcohol
Glycerin USP (Glycerol)
Excellent solvent for tannins, phenol and boric
acid. It has a preservative quality.
Glycerin USP (Glycerol)
miscible in water, acetone, alcohol and chloroform
Propylene Glycol
miscible in water, acetone alcohol and other glycols
Polyethylene glycol 400
miscible with alcohol, ether, benzene, hexane and both fixed and volatile oils
chloroform
miscible with water, alcohol, ether, chloroform and most of the volatile oils
Acetone
METHODS OF PREPARING SOLUTIONS
Simple Solution
Solution by Chemical reaction
Solution by Extraction
prepared by dissolving the solute in the solvent
Simple Solution
prepared by reacting two or more solutes with each other in a suitable solvent.
Solution by Chemical reaction
vegetables or animal origin are often extracted with
suitable solvent. Preparation of this type may be classified as solutions but more often EXTRACTIVES
Solution by Extraction
used as a major ingredient. Water is used as a vehicle
and a solvent for the desired flavoring or medical agent
AQUEOUS SOLUTIONS
CHARACTERISTICS OF WATER
o Tasteless
o Freedom from irritating qualities
o Lack of pharmacologic activity
PREPARATION IN AQUEOUS SOLUTIONS
o Distillation
o Demineralization or Deionization
o Reverse Osmosis
This ionization process is the well-known Zeolite process of softening water high mineral content.
Demineralization or Deionization
act as a catalyst such as dehydrated aluminum
Zeolite
the water should be ___before they can be used for pharmaceuticals
purified
Transport of solvent through semipermeable membrane separating 2 solutions of different concentrations (less
concentrated and more concentrated
Reverse Osmosis
A reversely new separation process w/c in principle may be applied to the separation, concentration and fractionalization of inorganic or organic substances in aqueous or non-aqueous solutions in the liquid or the gaseous phase is known
reverse osmosis
reverse osmosis also referred as “__ “ membrane
filtration
“crossflow or tangential flow”
Aromatic water is also called
medicated water
defined in the USP as clear, saturated aqueous solutions of volatile oils or other aromatic or volatile substances
AROMATIC WATERS
2 Components of aromatic water
- Volatile oil
2. Water
Official Processes of Preparation in aromatic water
Distillation
Solution Method
is the process of obtaining aromatic water by distillation one or more times from delicate drugs with small quantities of volatile principles
Cohobation
Example of cohobation
Stronger Rose (Aqua Rose Fertier, Triple Rose Water)
Solution Method
❑ Simple Solution Method
❑ Alternate Solution by Intervention
volatile material is mixed thoroughly with __ g of purified talc
15
T or F
Aromatic water are not permanently stable preparations
True
aqueous solution which is directed against a part or into a cavity of the body. It functions as a cleansing or antiseptic.
Douche
Douches are usually directed to the appropriate body parts by using
Bulb syringe
vaginal syringe is made up of an ___ ounce capacity bulb syringe with a large vulcanite or rubber spray tube
8 to 10
KINDS OF DOUCHES
Eye douche
Pharyngeal douche
nasal Douche
Vaginal douche
Vaginal Douche are also called
urethral douche or irrigation
Enema are also called
clyster
Enemas are usually given at body temperature in quantities of ___ injected slowly with enema syringe
1 to 2 pints
If they are to be retained in the intestine, they should not be used in larger quantities than __ ounces for an adult
6 fluid
Enema of soft soap - prepared by dissolving __ g of soft soap with purified water to make __
50
1000 mL
TYPES OF ENEMA
Evacuation Enemas
Retention Enemas
Nutritive Enema
Medicated Enema
rectal enemas employed to promote evacuation of bowel and to cleanse the colon for retention and for diagnosis - toenema
Evacuation Enemas
a number of solutions are administered rectally for the local effects of the medication - toenema
Retention Enemas
supply nutrient to thepatient - toenema
Nutritive Enema
supply medication for systemic effect- - toenema
Medicated Enema
BaSO4 and Fleet Enema - toenema
Diagnostic Enema
Are aqueous solutions used for treating the pharynx and nasopharynx by forcing air from the lungs
gargles
Examples of gargles
Phenol Gargle and Potassium Chlorate (also known as Golden Gargle) and Phenol Gargle are official in B.P.C
Latin name of phenol gargle
Gargarisma Phenol
Contains 50mL of Phenol Glycerin (__ % w/w pheno and __% w/w glycerin), __ amaranth solution ( __%w/v in chloroform water) and water to make 1L
16%, 84%
10mL, 1%
an aqueous solution which is most often used for its Deodorant Refreshing Antiseptic effect
mouthwash
washes also called
LAVATIO ORI
Eye washes- as anesthetic, anti-infective, diagnostic, myotic and anti-inflammatory
Collyrium
Mouthwash - antibacterial
Collutorium
Nasal wash - antibacterial and antiseptic
Collunarium
Juices are formerly known as
INPISSATED JUICES
Example of Juices
Cherry juice and Raspberry juices are official in USP
concentrated solutions of sugar (such as sucrose) in water or other aqueous liquids with or without added flavoring agents and medicinal substances
Syrups
3 Types of syrups
Simple syrup
Medicated syrup
Non-medicated/Flavored syrup
concentrated solution of sucrose in purified
water alone
Simple syrup
aqueous solution of sucrose containing other substances as polyols(glycerin and sorbitol)
Medicated syrup
contained various aromatic and pleasantly flavored substances and is intended as a vehicle or flavor for preparations.
Non-medicated/Flavored syrup
are used as vehicles and have no official formulas and therefore no detailed descriptions of the product are found in compendia.
Non-medicated/Flavoring syrups
Pharmaceutical Classification
• Based on their basic formula
- sugar based syrups
- artificial sweeteners and non-nutritive syrups
syrups which are concentrated solutions
sugar based syrups
formulated with artificial sweetening agents and viscosity builders
artificial sweeteners and non-nutritive syrups
This sucrose - based syrup utilizes sweet orange peel tincture, and citric acid as the source of flavor and tartness
Orange Syrup
syrup of orange peel, sweet orange peel __ mL;citric acid __ g; talc __ g; sucrose __ g; purified water q.s to
make __ mL
Syrupus Aurantii 50 mL 5 g 15 g 820 g 100 mL
Commercially available vehicles for the extemporaneous compounding of Syrups.
Ora - Sweet and Ora-Sweet SF
Sugar free
Ora-Sweet SF
A sucrose - based syrup containing about __% by volume of raspberry juice
Raspberry Syrup
48%
Licorice syrup, Glycyrrhiza fluid extract __ mL; Fennel oil __ mL; Anise oil __ mL; syrups, q.s to make __ mL
Glycyrrhiza Syrup 250 mL 0.55 mL 0.5 mL 1000 mL
Cocoa Syrup =
Syrupus cacao, Cacao syrup
Cocoa Syrup chocolate flavored, cocoa __ g; sucrose __ g ; liquid glucose __ g; glycerin __ mL;
Sodium chloride __g; Vanilla __ g ; Sodium benzoate __g ; water q.s. to make 1000 mL
180 g 600g 180 g 50 mL 2 g 0.2 g 1 g
Cherry Syrup =
Syrupus Gerasi
Cherry juice __ mL; sucrose __; alcohol __ ; water q.s. to make 1000 mL
475 mL
800 g
20 mL
Acacia Syrup=
Syrupus acaciae
Acacia Syrup
Acacia powder __ g; Sodium benzoate __ g; Vanilla tincture __ mL; Sucrose __ g; Purified
water q.s to make 1000 mL.
100 g
1 g
5 mL
800 g
Citric acid Syrup =
Syrupus Acidi Citrici, Syrup lemon
Citric acid Syrup -
Lemon tincture __ mL; Citric acid __ g: Purified water q.s to make 1000
mL
10 mL
10 g
may be used as the basis for the preparation of
flavored or medicated syrup
Simple syrup
Simple Syrup has __ % sucrose in purified water
85%
COMPONENTS OF SYRUPS
Sugar Antimicrobial preservatives Flavorants colorants Miscellaneous
PRESERVATION AND STORAGE OF SYRUPS
Generally, syrups are stored at ___ in tightly closed bottle and well-filled bottles
room temperature
PRESERVATIVES SYRUPS
- Benzoic acid- __ %
- Sodium benzoate – __ %
- Combination of methyl, propyl, butyl parabens totaling= %
- 1% to 0.2%
- 1 to 0.2
- 1%
Honey is also called
“Clarified honey” or “Strained Honey”
Honey instead of __ was used as a base for thick liquid preparation known as
Syrup
Honeys or Mels
___ the secretion deposited in the honeycomb of the bee and consists of a mixture of invert sugar – __ %; sucrose – __ %; dextrin – __%
Honey
62-83%
8%
0.2%
Honeys example
Oxymel (acid honey) – contains acetic acid – __ mL; Purified water __ mL; honey q.s to make 1000 mL
150 mL
150 mL
Are thick, viscid, adhesive liquids, produced by dispersing gum in water or by extracting with water mucilagenous principle from vegetable substances
MUCILAGES
used primarily to aid in suspending insoluble substances in liquids
MUCILAGES
Are liquid preparation composed by pyroxylin dissolved a solvent mixture. Usually composed of alcohol and ether with or without added substances
COLLODIONS
is obtained by the action of mixture of nitric acid and sulfuric acids on cotton and consists chiefly of cellulose tetranitrate.
• Pyroxylin (nitrocellulose soluble gun cotton, collodion cotton)
applied to the skin by means of a soft brush or other suitable applicators. The solvent rapidly evaporates, leaving a film residue of pyroxylin
Collodion
protective coating collodion
Collodion, USP is a clear or slightly opalescent viscous
liquid prepared by dissolving __% W/V pyroxillin in __ mixture of ether and alcohol
4%
3:1
protective coating collodion
___ is prepared by adding __% of Camphor and __% castor oil to the Collodion
Flexible Collodion, USP
2%
3%
provides medication collodion
__ % solution of salicylic acid in flexible collodion. Used as keratolytic effect t ( topical drug that softens the superficial keratincontaining layer of the skin and promotes its desquamation) especially in the removal of corns from the toes.
Salicylic acid Collodion, USP
10%
Salicylic acid Collodion, USP synonym
Corn solvent
• Are clear, pleasantly flavored, sweetened hdyroalcoholic liquids intended for oral as compared to syrup, elixirs are less sweet and viscous since they contain a lower portion of sugar and consequently less effective in masking the taste of medicinal substances
Elixirs
Elixir is by __ solution
simple solution
Elixir main ingredient
ethanol and water
Elixir
The alcohol content varies from __% depending on the water alcohol solubility of the ingredients
3 to 41 %
Preparation of Elixirs
- Simple solution with agitation
2. By the admixture of two or more liquid ingredients
Classes of Elixirs
Medicated and nonmedicated elixirs
Solutions of mixtures of medicinal or pharmaceutical substances in glycerin
GLYCERITES
Generally, a minimum of __ % of glycerin is present in glycerites
50%
Glycerites possess preservative properties?
true
A drugs or combinations of drugs the by virtue of their high vapor pressure can be carried by a current into the nasal passage where they exert their effects.
INHALATIONS/INHALANTS
The device in which they bare administered is termed an (in inhalation)
inhaler
treatment of anginal pain (inhalant)
Amyl Nitrite inhalant
nasal decongestant (inhalant)
Propylhexedrine inhalant
Are alcoholic or oleaginous solutions or emulsions of various medicinal substances intended for external application to the skin, generally with
rubbing
Liniments
LINIMENTS are formerly called
“embrocations”
Liniments are prepared in the different manner as solutions, emulsions or suspensions
False
Just read
All liniments Must Bear a Label Indicating
- for external use only
- Shake well for emulsion or suspension
- Store in tight containers
- Not to be applied to bruises or broken skin areas
Formerly called “Essences”
SPIRITS
alcoholic or hydroalcoholic solutions of volatile substances.
SPIRITS
Brandy =
___ % alcohol from grapes
Spiritus Vini vitis
48 to 54%
Whisky = __
__ of alcohol from cereals
Spiritus frumenti
47 to 53%
Majority of spirits are prepared by dissolving the solute in alcohol by agitation. Filtration is generally desirable to obtain a sparking clear product
Simple solution
Example of what method
Aromatic Spirit - __% hydroalcoholic solution of ammonia and ammonium carbonate flavored and perfumed with lemon, lavender and myristica oil.
Simple Solution
62 to 68%
Macerate the vegetable materials in a suitable solvent to remove the undesired constituents or to extract one which is desired
Solution with Maceration
Peppermint Spirit
– __ % hydroalcoholic solution containing __ %
peppermint oil
79 to 85%
10%
Peppermint Spirit=
Spiritus Menthae Piperitae
Only the preparation of Aromatic Spirit of Ammonia NF, involves a chemical reaction where the official Ammonium carbonate
Solution by Chemical Reaction
No spirits currently official are prepared by distillation, However, two products of historical significance which is official in NF are prepared by distillation.
Examples:
Brandy and whisky
Distillation
Are preparations used for the temporary relief of toothache by application of a small cotton saturated with the product into the tooth cavity
TOOTHACHE DROPS
The word emulsion, came from____, “meaning ___
emulgio
to milk out
Is a dispersion in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible
Emulsions
The dispersed phase is referred to as the
Internal phase
dispersion medium as the
External or Continuous phase
Emulsions having an oleaginous internal phase and aqueous external phase are referred to as
oil-in-water (o/w) emulsions
Emulsions having an aqueous internal phase and an oleaginous external phase are termed
water-in- oil (w/o) emulsions
Just read
O/W emulsion may be diluted with water or an aqueous preparation, & W/O emulsion with an oleaginous or oil miscible liquid
Just read
▪ The aqueous phase may contain water-soluble drugs, preservatives, coloring and flavoring agents
▪ The oil phase frequently consists of fixed oil or volatile and drugs that exist as oil, such as oil soluble vitamins and antiseptic
Just read
It is necessary to add antioxidant to prevent autoxidation of the oil and rancidity/and or destruction of any vitamin present
emulsions useful as vehicle to develop the bioavailability of poorly absorbed drugs
O/W emulsions
For orally administered emulsion permits the palatable administration of an otherwise distasteful oil by dispersing it in a sweetened, flavored vehicle.
O/W
On the unbroken skin __ emulsion
W/O
easily removed from the skin __ emulsion is preferred
O/W
Results in the lowering of the interfacial tension of the 2 immiscible liquids, reducing the repellant force between the liquids and diminishing each liquids attraction for its own molecules
Surface Tension Theory
tension lowering substances are referred to as
surface active (surfactants) or wetting agents
Assumes monomolecular layers of emulsifying agent curved around a droplet of the internal phase of the emulsion
Oriented-Wedge Theory
is based on the presumption that certain emulsifying agents orient themselves about and within a liquid in a manner reflective of their
solubility in that particular liquid
Oriented-Wedge Theory
An emulsifying agent having a greater hydrophilic character than hydrophobic character will promote an O/w emulsion and a W/O emulsion result through use of more hydrophobic than hydrophilic
emulsifiers
Oriented-Wedge Theory
Places the emulsifying agent at the interface between the oil and water, surrounding the droplets of the internal phase as a thin layer of film
adsorbed on the surface of the drops
Plastic or Internal Film Theory
prevents the contact and the coalescence of the dispersed phase
Plastic or Internal Film Theory
the tougher and more pliable the film, the greater the stability of the emulsion
TRUE
States that the viscosity of an emulsion aids emulsification by the mechanical hindrance to coalescence of the globules although it is not the cause of emulsification.
Viscosity Theory
These materials form hydrophilic colloids when added to water and generally produced O/W emulsions
Natural emulsifying agent
Most frequently use Natural emulsifying agent
Acacia
thickening agents in Acacia emulsified products
Tragacanth and Agar
Natural emulsifying agent proteins
gelatin, egg yolk, casein
These materials employed primarily as thickening and stabilizing agents for O/W emulsions such as lotion and ointments
High Molecular Weight alcohols
may also be employed in externally used emulsion and promote W/O emulsions
Cholesterol
These materials generally form O/W emulsions when the insoluble material is added to the aqueous phase if there is greater volume of the aqueous phase than of the oleaginous phase
Finely divided solids
Synthetic (wetting agents), which may be
▪ Anionic: triethanolamine oleate and sodium lauryl sulfate
▪ Cationic: benzalkonium chloride
▪ Nonionic: sorbitan esters (span); polyethylene glycol 400 monostearate; polyoxyethylene sorbitan esters (Tweens)
Just read
Qualities Required for Emulsifiers
▪ Must be compatible with other ingredients in the formula
▪ Must not interfere with the stability and efficacy of the therapeutic agent
▪ Must be stable to microorganisms
▪ Must be non-toxic
▪ Must possess little or no odor, taste or color 6. Must promote emulsification and maintain stability of the emulsion for intended shelf-life
HLB or Hydrophilic-Lipophile Balance usual range
between 1 to 20
Surfactants having an assigned HLB value from __ are greatly lipophilic and produce W/O emulsions
3 to 6
those HLB values of from
about ____ produce O/W emulsions
8 to 18
In selecting an Emulsifier for an emulsion, choose one having the same or nearly the same HLB value as the oleaginous phase
True
Just read
▪ Ex.: Mineral oil has assigned HLB of 4 if a W/O emulsion is desired and a value of 10.5 if O/W emulsion is prepared
▪ Therefore, use surfactant SPAN 80 (Sorbitan monoleate) with HLB 4.3 for W/O emulsion and methylcellulose with HLB of 10.5 for O/W
The method is also referred to as the “4:2:1” because for every 4 parts (volumes) of oil, 2 parts of water and 1 part of gum are added in preparing the initial or primary emulsion.
Continental or Dry gum method
A mortar with a rough rather than smooth inner surface must be used to ensure proper grinding action and the reduction of the globule size during the preparation of the internal phase emulsion. A glass mortar has too smooth a surface to produce the proper size reduction of the internal phase
True
For the extemporaneous preparation of emulsions from volatile oils or oleaginous substances of low viscosities, the bottle method is used.
(2:2:1)
English or wet gum method Bottle or Forbes bottle method (G+O+W)
In SITU soap method
Two types of soap developed by this method are
Calcium soaps and Soft soaps.
The diameter of droplets in a microemulsion may be in the range of ___
A (10 microns) to 1000 A whereas in a microemulsion the droplets may be ___ angstroms in diameter
100
5000
is the joining together of globules to form large clumps or floccules which rise or settle in the emulsion more rapidly than do the individual particles
Flocculation
is the rising or settling of globules or floccules to form a concentrated layer at the surface or to the bottom of the emulsion
Creaming
is taking up of a certain amount of liquid without a measurable increase by a gel with an increase volume
Imbibition
is the taking up of a liquid by a gel with an increase in volume. Only those liquid that solvate a gel
Swelling
is when the interaction between particles of the dispersed phase becomes so great than on standing, the dispersing medium is squeezed out in droplets and the gel shrinks
Syneresis
a form of instability in aqueous and no aqueous gels
Syneresis
a reversible gel-sol formation with no change in volume or temperature-a type of non-Newtonian flow
Thixotrophy
is formed when the liquid is removed from a gel and only the framewok remains
Xerogel
Is a two-phase system consisting of a finely divided solid dispersed in a liquid vehicle
Suspensions
finely divided particles are also referred to as
‘Suspensoids”
Suspensions
the substance distributed is referred to as
dispersed phase
Suspensions
the vehicle is termed the
dispersing phase or dispersion medium
Dispersions containing coarse particles, usually ___ um in size, are referred to as ___
coarse dispersion.
10 to 50 um
Dispersions containing particles of smaller size are termed ___ usually in a range of __
fine dispersions
0.5 - 10 um
Suspensions for injections must contain particles size such that they can pass freely through the syringe needle called
“syringeability”
Ophthalmic suspension should be formulated such that the particles do not exceed __ microns
10 microns (less than 10 microns)
They are liquid suspension or dispersion intended for external application to the skin, frequently containing suspended particles or emulsified liquid droplets
LOTIONS
aqueous suspensions of insoluble, inorganic drugs and differ from gels mainly in that the suspended particles are larger.
MAGMAS & MILK
oral liquids containing one or more active ingredients, dissolved, suspended or dispersed in a suitable vehicle
MIXTURES
semisolid systems consisting of small inorganic particles suspended
in a liquid medium
Gels
It consists of a network of small discrete particles
Gels
involves the separation of medicinally active portions of plant or animal tissues from the inactive components through the use of selective solvents
Extraction
Galenicals include classes of preparations knows as
o Decoction o Infusion o Fluidextracts o Tinctures o Pilular (semi solid) extracts o Powdered extracts
Maceration (Process M)- term derived from latin word __ meaning to soak.
“macerare”
Process in which the properly comminuted drug is permitted to soak in the menstruum and the soluble constituents are dissolved
Maceration (Process M)
Just read
Percolation –
Per =“through”; Colare = “strain”
The process in which the comminuted drug is extracted of its soluble constituents by the slow passage of a suitable solvent through a column of drug
Percolation
The drug is packed in a special extraction apparatus termed as ___ with the extractive collected called the __
percolator
percolate
Cylindrical with little if any taper except for the lower orifice also called
Oldberg percolator
form of maceration with gentle heat
Digestion
process in which vegetable drugs, generally coarsely comminuted, are extracted of the water-soluble constituents
Infusion
process of boiling vegetable substances with water to extract the soluble principle
Decoction
defined as alcoholic or hydro alcoholic solution prepared from vegetable material or from chemical substance
TINCTURES
Topical solutions employ an ___
aqueous vehicle
topical tinctures characteristically employ an ___
alcoholic vehicle
Jus read
Topical solutions and Tinctures are prepared by simple solution and self -preserved.
Methods of Preparation of Tinctures
By simple solution
By simple solution
Methods of Preparation of Tinctures
tinctures prepared from chemical substances
By simple solution
Methods of Preparation of Tinctures
by maceration or percolation
By extraction
Alcohol Content of Green soap Tincture
28 to 32% alcohol
Alcohol Content of Tolu Balsam Tincture
77 to 83% alcohol
liquid preparations of vegetable drugs containing alcohol as a solvent or as a preservative or both, and so made that each mL contains the therapeutic constituents of 1g of the standard drug that it represents
FLUIDEXTRACTS
true or false
Fluidextracts are sometimes referred to as “100% tinctures”
True - ▪ Because they contain alcohol and are highly concentrated
true or false
Fluidextracts of potent drugs are ten times as concentrated or as potent
as corresponding tincture
True
Preparations of Fluidextracts
- entails exhaustive percolation with an alcoholic or
hydroalcoholic menstruum
Process A
Preparations of Fluidextracts
- is used in the preparation of fluidextract with boiling water as the menstruum and alcohol generally added to the concentrated percolate as preservative. A heat resistant or metallic percolator is used
Process B or D
Preparations of Fluidextracts
- is intended to facilitate total drug extraction by
collecting 1000 mL of percolate from each 1000 g of drug, uses long narrow column of drug and percolation under pressure
Process C and E
are concentrated preparations of vegetable or animal drugs obtained by removal of the active constituents of the respective drugs with suitable menstruum, evaporation of all or nearly all the solvents, and adjustment of the
residual masses or powders to the prescribed standards
Extract
Just read
Methods of Preparation in extraction
Prepared by percolation then evaporation of the solvent either by
distillation under pressured and using reduced heat
Just read
3 Forms of Extract (depending upon the extent of the removal of solvent)
▪ Semiliquid extracts are those of a syrupy consistency
▪ Pilular or solid extracts of a plastic consistency
▪ Powdered extracts prepared to be dry by the removal of all the solvent
True or false
Packaging and Storage of Extracts
Must be packaged in wide mouth containers or plastic tubes and closely tight to prevent loss of moisture which would result in its becoming hard and unstable for use
True
The term parenteral derived from the Greek words
para (outside) and enteron, (intestine)
Refers to the injectable routes administration
PARENTERALS
joints
Intra-articular
spinal column
Intraspinal
arteries
Intra-arterial
veins
Intravenous
shin
Intradermal
joint fluid
Intrasynovial
spinal fluid
Intrathecal
heart
Intracardiac
muscles
Intramuscular
under the skin
Subcutaneous
Generally, the flow rates of IV are expressed in ___ range from __
mL/hr
42 to 150 mL/hour
Hazard of Intravenous Injection
The possibility of thrombus formation - induced by the touching of the wall of the vein by the catheter or needle
s a blood clot formed within the blood vessel (or heart) due usually to a slowing of the circulation or to an alteration of the blood or vessel wall
Thrombus
Once such a blot circulates, it becomes an ___ - carried by the blood stream until it lodges in a blood vessel, obstructing it, and resulting in blockage
or occlusion referred to as an ___
embolus
Embolism
provide effects that are less rapid, but generally of greater duration than those obtained from intravenous administration
Intramuscular injections
True or false
IM are not performed deep into the skeletal muscles
False
IM : limited : ___ in the gluteal region
5 mL
IM : in the deltoid of the arm
2 mL
IM: Injection
is __ inches deep; __ gauge needle
2 to 3 inch
20 to 22
technique useful for IM injections of medications that stain upper tissue
Z-Track Injection
May be utilized for the injection of small amounts of medication or of drugs beneath the surface of the skin of the upper arm, the anterior surface of the thigh, and the lower portion of the abdomen
lower portion of the abdomen
SUBCUTANEOUS ROUTE (
The maximum amount of drug given SC is about
1.3 mL
SC: Syringes- up to __ capacities
3 mL
SC: Utilizing needles __ gauge
24 to 26 gauges
SC insulin needles: gauge between ___ ; needle length between ___ to __ inch
25 to 30
5-16
5-8 inch
Substances may be effectively injected into the corium, the more vascular layer of the skin just beneath the epidermis
INTRADERMAL ROUTE
INTRADERMAL ROUTE
These substances include
diagnostic determinations, desensitization, or
immunization
INTRADERMAL ROUTE
Usual site
anterior surface of the forearm
Just read
A short (3-8 inch) and narrow gauge (23 to 26) is inserted horizontally into the skin with the bevel facing upward. The injection is made when the bevel just disappears into the corium
INTRADERMAL ROUTE
needle volume is
about 0.1 mL
long-acting injections are called
respiratory or depot preparations
Injections true or false
The use coloring agents is strictly prohibited
True
Parenteral products are packaged in special ___ containers of specific and highly quality
hermetic
Water for Injection is required to be sterilized, it must be pyrogen free
False (not required to be sterilized )
This water is purified by distillation or by reverse osmosis.
Water for Injection, USP
▪ may not contain other substances
▪ meets standard for the presence of total solids
Purified water, USP
▪ is water for injection which has been sterilized and packaged in single
dose containers of not greater than IL size
▪ as water for Injection, it must be pyrogen free and may not contain an
antimicrobial agent or other added substance
Sterile Water for Injection, USP
▪ is sterile water for injection containing one or more suitable
antimicrobial agents.
▪ it is packaged in pre-filled syringes or in vials containing not more than
30 mL of the water. Label must state, “Not for Use in Newborns”.
Bacteriostatic Water for Injection, USP
▪ a sterile isotonic solution of sodium chloride in Water for Injection.
▪ It contains no anti- microbial agents
Sodium Chloride Injection, USP
Sodium chloride concentration is __% to render isotonic solution. It is also used to flush a catheter or IV line to maintain its patency.. “Not for Use in Newborns”
Bacteriostatic Sodium Chloride Injection
0.9%
▪ is a sterile solution of sodium chloride, potassium chloride, and calcium
chloride in water for injection.
▪ It is used as electrolyte replenisher and a systemic alkalizer.
▪ Lactated R = Na lactate
Ringer’s Injection, USP
must be present in adequate concentration at the time of use to prevent the multiplication of microorganism.
Antifungal/Antibacterial
Antifungal/Antibacterial
__ %; for agents like chlorobutanol, cresol
phenol -___%
- 01 %
0. 5%
one of the pathways of degradation which can be accelerated during thermal sterilization.
Oxidation
Antioxidants- Sulfur dioxide - %
0.2%
antioxidants which functions by being
preferentially oxidized
Reducing agents
antioxidants which block an oxidative chain reaction in which they are not usually consumed
Blocking agents
compounds increase the effectiveness of antioxidants, particularly those blocking oxidative reactions
Synergists
those that complex with catalysts which otherwise would accelerate the oxidative reaction
Chelating agents
Inert gases like ___ have been used to
displace oxygen from a solution and reduce the possibility of oxidative changes in the formulation
nitrogen and carbon dioxide
added to maintain the required pH for many products; a change in pH may cause significant alterations in the rate of degradation reactions
Buffers
The principal buffer systems used to stabilize pH are the
Acetates
Citrates
Phosphates
Compounds contributing to the isotonicity of a product reduce the pain of injection in areas with nerve endings
Tonicity Contributors
Containers for sterile products are made of ___
glass or plastic
Two general types of glass
▪ soda-lime
▪ borosilicate
glass compounds are classified into 4 types
highly resistant borosilicate glass
Type I
glass compounds are classified into 4 types
treated soda-lime glass
Type II
glass compounds are classified into 4 types
soda lime glass
Type III
used to seal the openings of catridges, vials and bottles, providing a material soft and elastic enough to permit entry and withdrawal of a hypodermic needle without loss of the integrity of the sealed container
Rubber closures
the complete destruction or elimination of microbial life.
Sterilization
conducted in an autoclave and employs steam under pressure
Steam distillation
usually carried out in sterilizing ovens specifically designed for this purpose. The ovens may be heated either gas or electricity and generally thermostatically controlled. It is conducted at temperatures of ___ for periods not less than 2 hours
Dry-heat sterilization
1600C to 1700C
This is a nonthermal method for the sterilization of select solutions by removing microorganisms from the solution while permitting the passage of all the desired components of the solution and imparting no undesirable components from the filter
Sterilization by filtration
Sterilization by filtration
available in pore sizes from
14 to 0.025 um.
Sterilization by filtration
The size of the smallest particle visible to the naked eye is about __ , a red blood cell is about __ , the smallest bacteria, about__ , and a polio virus, about 0.025 um
40 um
- 5 um
- 2 um
believed to exert its lethal effect upon microorganisms by alkylating essential metabolites, affecting particularly the reproductive process.
Ethylene oxide
acceptable practical method for sterilizing
plastic
Ethylene dioxide
sterilization
Just read
▪ Sterilization by ionizing radiation
Ionizing Radiations are highly radiations emitted from
radioactive isotopes such as cobalt-60 (gamma rays) or produced by mechanical acceleration of electrons to very high velocities and energies (cathode rays, beta rays).
Ionizing radiations destroy microorganisms by stopping
reproduction as a result of lethal mutations
fever producing organic substances arising from microbial contamination and responsible for many of the febrile reactions which occur in patients following injections
Pyrogens
obtained from aqueous extracts of the circulating amebocytes of the horseshoe crab, Limulus polyphemus, and which has been prepared & characterized for use as an LAL reagent for gel-clot formation
Limulus Amebocyte Lysate (LAL)
The test involves measuring the rise in temperature of rabbits
Pyrogen Test
If no rabbit shows an individual rise in temperature 0.60C or more above its respective control temperature, and if the sum of the 3 individual maximum temperature rises does not exceed __, the product meets the requirements for the absence of pyrogens
1.40 degree celcius
is a useful method for evaluating the efficiency of the sealing process.
Leaker’s test
the test consists of immersing completely the sterile sealed ampules in an aqueous dye bath ___ % within a vacuum chamber.
0.5 to 1.0% of methylene blue
a sterile aqueous solution of insulin. It is prepared from beef or pork pancreas or both or through biosynthetic means (Human Insulin).
Insulin Injection
Just read
Insulin
With a pH of 2.8 to 3.5. Insulin Injection is prepared to contain 100 or 500 USP
Insulin Units in each mL
Expiration of . Insulin Injection (regular)
Not to be later than 24 months after the date of distribution
It is produced by utilizing a special non-disease forming laboratory strain of Escherichia coli and recombinant DNA technology
Human Insulin
consists of Zinc-insulin
crystals in solution. It has a rapid onset of action and relatively short duration of action (6 to 8 hours)
Neutral Regular Human Insulin (Humulin R)
is a turbid preparation that is intermediate acting, with a slower onset of action and longer duration of action (slightly less than 24 hours) than regular insulin
NPH Human Insulin (Humulin N) -
Is a sterile suspension, in an aqueous vehicle buffered with dibasic sodium phosphate to between pH ____ of insulin prepared from zinc-insulin crystals modified by the addition of protamine so that the solid phase of the
suspension consists of crystals composed of insulin, zinc, and protamine
Isophane Insulin Suspension (NPH Insulin)
7.1 and 7.4,
prepared from the sperm or the mature testes of fish belonging
to the genus Oncorhynchus
Protamine
Isophane Insulin Suspension (NPH Insulin)
Expiration date
24 months
Isophane Insulin Suspension (NPH Insulin)
dosage range
10 to 80 USP Units
Humulin 70/30, Humulin 50/50 contains ___and their preservatives are
0.01 to 0.04 mg/100 units
m-cresol and phenol
modified by the addition of zinc chloride so that the suspended particles
consist of a mixture of crystalline and amorphous insulin in a ratio of approximately 7 parts of crystals to 3 parts of amorphous material
Insulin Zinc Suspension
These solutions are usually administered by IV infusion to replenish body fluids, electrolytes, or to provide nutrition
LARGE VOLUME PARENTERALS (LVP)
LARGE VOLUME PARENTERALS (LVP) are usually administered in volumes of
100 mL to liter
Normal water requirement for adult
25 to 40
mL/kg of body weight or an average of about 2,000 mL per square meter of body surface area
Estimate guidelines in normal daily requirement for water
<10 kg
10-20kg
>20 kg to maximum of 80 kg
100 mL/kg/day
1000 mL plus 50 mL/kg/day
1500 mL Plus 20 mL/kg/day
important for cardiac and skeletal muscle function
The usual daily
intake is about __ mEq and the usual daily loss is about __ mEq
Potassium
100
40
Low potassium levels
Hypokalemia
Excess potassium
Hyperkalemia can cause kidney
failure
is vital to maintain normal extracellular fluids
Sodium
SODIUM
Average daily intake of sodium
135 to 170 mEq (8 to 10 g of Sodium chloride)
Sodium loss/deficit
3 to 5 g sodium chloride (51 to 85 mEq of sodium)
is administered daily
The principal anion of the extracellular fluid usually paired with sodium
Chloride
also important for muscle contraction, balancing the fluid levels inside and outside the cells & maintaining the acid-base balance of the extracellular fluid
Chloride
the fasting state, the average daily loss of body proteins is approximately__ man
80g/day for a 70 kg
Generally, patients requiring parenteral fluids are given _% dextrose to reduce caloric deficit
5%
This is the infusion of large amounts of basic nutrients sufficient to achieve active tissue synthesis and growth.
Parenteral hyperalimentation
Pellets or Implants about __mm in diameter and __ mm in length
3.2 mm, 8mm
implanted under the skin (thigh or abdomen) with special injector or by surgical incision - used for potent hormones
pellets
intended to bathe or wash wounds, surgical incisions, or body tissues
Irrigation Solutions
This solution is employed topically to the bladder as a 0.25% solution for irrigation. It is administered to wash blood and surgical debris away while maintaining suitable conditions for the tissue
Acetic acid Irrigation, USP
Employed as a topical antibacterial in the continuous irrigation of the bladder
Neomycin and Polymixin B Sulfate Solution for Irrigation, USP
- It is used topically as an irrigation and must be
labeled “not for injection”. The solution is sterile and pyrogen free.
Ringer’s Irrigation, USP
This solution is employed topically to wash wounds and into body cavities where absorption into the blood is not likely. The solution also employed rectally as an enema for simple evacuation and also for colonic flush.
Sodium Chloride Irrigation, USP
The label designations “for irrigation only”
and “not for injection” must appear prominently on the label. The water must not contain any antimicrobial or other added agent
Sterile Water for Irrigation, USP
Solutions allowed to flow into the peritoneal cavity, are used to remove toxic substances normally excreted by the kidney
Peritoneal Dialysis
▪ Is employed to remove toxins from the blood. In this method, the arterial blood is shunted through a polyethylene catheter through an artificial dialyzing membrane bathed in an electrolyte solution.
Hemodialysis
