BUFFER

Raisa Cababa

solution usually containing

an acid and a base, or a salt, that
tends to maintain a constant
hydrogen ion concentration

REASONS FOR CONTROLLING PH

1. chemical stability
2. solubility of the drug
3. patients comfort

FACTORS WHICH CAN PRODUCE

ALTERATIONS IN PH

Alkali in the glass

gasses
air

BUFFER SYSTEMS
are pair of related chemical compounds
capable of resisting large changes in the pH of
a solution
Composed of a weak acid and its salt or weak
base and its salt.
Exhibit chemical stability
Avoid volatile species like ammonia and
carbon dioxide

 The buffer pair will complement each other

They will react with the conjugate base to form the
weak acid when small amounts of hydrogen ions
are introduced into the medium
When a small amount of hydroxide ion are
introduced into the medium they will react with the
weak acid to form water and the conjugate base

 Each component of the buffer pair will react with

either acid or base to form the other component
repressing large changes in hydrogen ion
concentration

 The buffer should not react with other chemicals in

the preparation.
The buffer pair should not:

1. Participate in oxidation-reduction reaction

2. Alter the solubility of other components
3. Form complexes with active ingredients

Inorganic Buffers which

have advantages in
pharmaceutical
preparations
phosphate buffer system
Borate buffer system

PHOSPHATE BUFFER SYSTEM

Advantage
Contains dihydrogen and monohydrogen
phosphate ions
Disadvantage
Insolubility of the phosphate salts of such metals
such as Ag, Zn, and Al
Supports microbial growth ex. Sorensen phosphate
buffer system

BORATE BUFFER SYSTEM

Toxic
Suitable in external preparations, ophthalmic
and nasal solutions
Contraindicated in parenteral solutions

3 PRIMARY BORATE BUFFER SYSTEMS

1. Feldmans Buffer System (pH 7-8.2)
-consists of:
acid solution containing boric acid
sodium chloride
alkaline solution containing sodium borate

2. Atkins and Pantin Buffer System (pH 7.6- 1 1)

-consists of:
alkaline solution of sodium carborate
acid buffer solution of boric acid and
sodium
chloride

 3. Gifford Buffer System (pH 6-7.8)

-consists of:
alkaline solution of sodium carborate
acid buffer solution of boric acid and
potassium chloride

SODIUM BORATE NF 26
Synonyms:
Borax
Sodium Pyroborate
Sodium Tetraborate
Tinkal

Properties:
Colorless
Transparent crystals
Compound is odorless and effloresces in warm,dry
air
Soluble in water and glycerin
Insoluble in alcohol
Its aqueous solutions are alkaline to
phenolphtalein

SODIUM BORATE
Used or formed in situ as the alkaline
member of the borate buffer system
Has the same toxicity as boric acid
Hydrolyzed to boric acid in aqueous
solution

Uses:
Best eyewash when acids happen to enter the
mucosa
Used in collyria
One of the components of mouthwashes and oral
preparetions
Powder to ulcers in the mouth
Weak bacterostatic agent
Forms borax soap which serves as emulsifying agent
for cold cream USP and Rose Water Oinment NF

PRODUCTS WITH SODIUM

BORATE

ANTIOXIDANTS
Alec Bernardo

Functioning chemically as reducing agents

Pharmaceutical preparations containing easily
oxidizable substances (e.g iodide or ferrous)
For a suitable oxidant
1. Physiologically inert
2. Possible toxicity must be assessed
3. Possible solubility problems between the reducing
agent and the drug
4. Forms explosive mixture when combined in dry form or
in concentrated solution

EXAMPLES

Hypophosphorous acid NF 26
Sulfurous Anhydride
Sodium Bisulfite
Sodium Metabisulfite NF 26

HYPOPHOSPHOROUS ACID NF
26
Properties
Colorless or yellow and odorless liquid
Contains n.l.t 30% and n.m.t 32% HPH O
Has a spec. grav. Of 1.13 @ 25 C
Pure acid is syrupy colorless liquid
2

Solid at 17 C
Melts at 26 C

HYPOPHOSPHOROUS ACID NF 26
Uses
Prevents formulation of free iodine in Diluted
Hydriodic Acid and Syrup
Prevents formulation of both ferric ions and
moleular iodine
Salts
Preservatives (ammonium hypophosphate)

SULFUR DIOXIDE NF26

Synonym: Sulfurous Anhydride
Properties
Colorless and Non-flammable Gas
Strong suffocating odor of Burning Sulfur
Contains n.l.t 97%
Under Pressure
Sulfur Dioxide condenses to a colorless liquid
Boils at -10 C
Density of 1.5
Soluble in water

SULFUR DIOXIDE NF26

Uses
Bleaching wood pulp
Fumigating grains
Gaseous nature
Used in injectable preparations enclosed in single
dose ampoules or vials

SODIUM BISULFITE
Synonyms: Sodium Hydrogen Sulfite, Sodium Acid
Sulfite, Leucogen
Properties
White or yellowish white crystals
Or granular powder
Garlic odor gas
N.L.T 57.5%
N.M.T. 67.4%
Unstable in air, giving off SO2

SODIUM BISULFITE
Uses
Used in almost all commercial wines to
prevent oxidation and preserve flavor
It can efficiently remove traces or excess
amounts of chlorine, bromine, iodine

SODIUM METABISULFITE NF 26
Properties
White crystal or yellow crystalline powder
Garlic odor gas
Contain an amount of Na2S2O5 equivalent to N.L.T
66% and N.M.T. 67% of SO2

SODIUM METABISULFITE NF 26
Uses
Found in acidic solutions of drug that
contains phenol
Prevents oxidation of the compounds to quinones

Water soluble deratives of normally

insoluble drugs
Menadione Sodium Bisulfite
Insoluble converted to a water soluble

NITROGEN NF 26
Properties:
Colorless gas
Inert gas
Non flammable
Usually solid in black cylinders

NITROGEN NF 26
Uses
Used to replace air in containers
Inter atmosphere
Retard oxidation inoxidation sensitive
products
Olive Oil, Cod liver oil

WATER
Juli-Anne Balais

PROPERTIES
Tasteless, odorless, clear liquid, colorless in
small quantities but greenish blue in deep layer
Has ability to form hydrogen bonds with other
water molecules or other electronegative or
positive ions or molecules

 Has a high dielectric constant

It is related to the separation of the charge
within the water molecule as a result of its
non-linear bent shape
Allows water to solvate ions readily and to
stabilize macromolecules
The small molecular size allows water to
penetrate into the free space within a
crystal and to break the ionic bond.

 Predominant constituent of the body

Small molecule and readily forming
hydrogen bonds
Solvent of choice in most liquid dosage
forms

HARDNESS OF WATER
Due to the presence of varying amounts of calcium, iron and/or
magnesium salts which convert ordinary soap into water
insoluble calcium, iron and /or magnesium salts of fatty acid
May be temporary or permanent
Temporary hardness (bicarbonate hardness)- caused by the
presence in the water of calcium or magnesium bicarbonates
Permanent hardness- caused by the presence in solution of
sulfates, chloride or hydroxides of calcium and/or magnesium

OTHER MEANS OF PURIFYING WATER

1. Addition of soluble carbonates which will precipitate calcium
and magnesium as insoluble carbonates.
2. Chelation by the Zeolite ( Permutit) Process- Zeolite is a
sodium aluminum silicate ( 2 O. 2 3 . 2Si2 . 32 O) with the
symbol of 2 Zeol. Passing the hard water through a zeolite
column, an exchange of water hardening cations is made
for non-hardening sodium cations.
3. Deionizer or Demineralizer- makes use of certain synthetic
resins whcih are endowed with removing both cations and
anions from water.
4. Polyphosate Chelation- being used by detergent industry to
chelate the divalent calcium making it unavailable for further
reaction using basic phosphate and sodium metaphosphate

OFFICIAL WATERS

1. PURIFIED WATER USP 31

Is water obtained by distillation or by ion exchange treatment
Clear and odorless liquid
Has specifications for:
pH
Calcium
Chloride
Carbon dioxide
Heavy metals
Sulfide
Oxidizable
Total solids
substances
Ammonia
Bacteriological
purity
It is water of choice for extemporaneous
compounding
and
preparation of most USP test reagents

2. WATER FOR INJECTION USP 31

Is water purified by distillation
It meets all the specifications called for in the
Purified Water monograph.
It is intended for use as a solvent for the
preparation of parenteral solutions.

3. STERILE WATER FOR INJECTION

USP 31
Is water for injection sterilized and suitably package
Most difficult to prepare
Stored in single-dose containers of not larger than
1000-mL size.
The label must indicate that no antimicrobial
substances has been added
It is used for extemporaneous compounding of
parenterals for either intravenous or intramascular
injection

4. STERILE WATER FOR INHALATION

USP 31
It is prepared from Water for Injection that is sterilized
and suitable packaged.
It contains no antimicrobial agents, except when
used as humidifiers or other similar devices and
where liable to contamination over period of time.
Intended for inhalation therapy
Packaged suitably in glass(type I or Type II) or plastic
containers

5. STERILE WATER FOR IRRIGATION

USP 31
Is prepared for Injection that is sterilized and
suitably packaged.
It contains no antimicrobial agents or other
substances
Suitably package in single-dose glass (type I or
Type II) or plastic containers with a volume of
more than 1 liter and maybe designed to
empty rapidly.

6. BACTERIOSTATIC WATER FOR

INJECTION USP 31
It is sterile water for injection containing one or
more suitable antimicrobial agents.
Benzyl alcohol is a common bacteriostatic
agent.
It is intended for compounding small volumes
of extemporaneous parentenals for
intramuscular injection.

 The bacteriostatic agent prevents the use of

this water for intravenous administration.
It is stored in a single-dose or in multiple-dose
containers of not later than 30 mL size
Label should be NOT FOR USE IN NEWBORNS

GLASS
Angelica Balisi

 Generic term referring to vitreous material

Sodium silicate
Vitreous material
Material that softens gradually over a
temperature
Transition in amorphous materials from hard
and brittle state to a molten rubber-like
state.

 Most commercial glasses are vitreous silicates with

types additives
Boron- decreases the coefficient of expansion of
Pyrex glasses.
Potassium- brown light resistant glass
Rare earth- absorb light of certain wavelength.

Aqueous solutions will slowly become alkaline in

soft glass containers.

4 TYPES OF GLASS IN THE

USP AND NF
USP- United States Pharmacopeia

TYPE I

Borosilicate glass
High degree of hydrolytic stability due to its
chemical composition.
Suited for:
Injectible products with acid
Neutral or slightly alkaline pH
Buffered aqueous solution below pH 7.0
Package water for injection, chemicals,
sensitive lab samples

 May be sterilized before and after filling

Resistance to sudden changes in
temperature
Least reactive glass available for
containers
Examples: Pyrex 7740

TYPE II
Treated soda-lime glass
Calcium-soda glass
When treated properly, can
reach the hydrolytic stability of
type I
Suited for:
Holding acid preparations
Holding neutral
preparations

TYPE III

Soda-lime glass
Used for dry powder and oily solution
Low alkaline content and high hydrolytic
resistance.
Not intended for pharmaceutical use
Suited for:
Packages for non-aqueous
preparations or in powder for
parenteral use
Non-parenteral preparations
Normally dry sterilized before being filled
Examples: Wheaton 800 and 900.

TYPE NP
General Soda-lime glass
Suitable for:
Capsules
Tablets
Topical products
Intended for packaging nonparenteral articles such as those
intended for oral or topical use
Examples : Wheaton 810 and 910.

TYPES OF CONTAINERS
Clear
Preferred for dispensing
The patient likes to see what he/she is buying
The amount left in the bottle
The ease of pouring

4 types of clear container

Colorless
Green
Blue
Amber
Protection from light

TYPES OF CONTAINERS
Opaque
The superior light
protective container
Except for ointments
Colored

QUESTIONS
HANGMAN

IT IS A TOXIC INORGANIC BUFFER WHICH

HAVE ADVANTAGES IN PHARMACEUTICAL
PREPARATIONS?
_______ ______ ______

IT IS A COMMON BACTERIOSTATIC AGENT?

______ _______

TYPE OF GLASS USED FOR HOLDING ACID

OR NEUTRAL SOLUTIONS
____ _

IT IS CAUSED BY THE PRESENCE IN THE

WATER OR CALCIUM OR MAGNESIUM
CARBONATES.

_________

________

ANOTHER NAME OF TYPE I GLASS

____________

_____

IT IS A COLORLESS COMPOUND THAT IS BEST

USE AS AN EYEWASH
______ ______

THEY ARE PAIRS OF RELATED CHEMICAL

COMPOUNDS CAPABLE OF RESISTING
LARGE CHANGES IN THE PH OF A SOLUTION
______ _______

TYPE OF WATER WHICH IS THE MOST

DIFFICULT TO PREPARE?

_______ _____
_________

___

SUPERIOR LIGHT PROTECTIVE LAYER?

______

END