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Buffers

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12 views28 pages

Buffers

Uploaded by

ankitkumar72009
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Buffers in Pharmaceutical Systems

Divided into 2 types:


1. Standard buffer system: These solution having standard pH used for analytical purpose
towards quality assurance.
2. Actual Pharmaceutical buffers:
Designed to maintain pH limits in pharmaceutical preparations.
 In case of parenteral preparations, pH should be considered carefully and the
ideal pH is 7.4, which is pH of blood. The most commonly used buffers in
parenteral products are acetate, phosphate, citrate and glutamate.
 In Ophthalmic preparations, buffers are generally used to maintain pH with
the physiological range of lacrimal fluid (eye fluid). The lacrimal fluid has a pH
range 7-8, but it has good buffering capacity and can tolerate preparations
having pH values between 3.5-10.5 with little discomfort. Outside this range
(3.5-10.5), increases lacrimation may occur with other complications.
The buffering agents used in ophthalmic preparations include borate, carbonate
and phosphates.
 In topical products (used in skin) such as ointments and creams are also buffered to
ensure stability to the formulation. The most commonly used buffers in ointments and
creams are citric acid/ its salts and phosphoric acid/ its salts.

 Optimizing biological activity: Optimum pH conditions for activity of medicinal compounds


have to be maintained. Enzymes contain most activity only on certain pH values. For
example, at pH 1.5, there is a maximum activity of pepsin.

 Stability of compounds
Because of hydrolysis, many compounds are unstable in aqueous solutions. These solutions
can be stabilized by regulating the pH.
• Ascorbic acid and penicillin are unstable in an alkaline pH.
• Sodium thiosulphate and sodium polysulphide preparations have to be stored at alkaline
conditions to prevent separation of sulphur.
 Solubility
• A controlled pH medium is helpful in controlling the solubility of compounds. For
example, in acidic medium, solubility of different compounds (inorganic salts of Fe+3,
phosphates and borates) is increased; but these inorganic salts precipitate in alkaline
media.
General Procedures for Preparing Pharmaceutical
Buffer Solutions

1.Select a weak acid having a pKa approximately equal to


the pH at which the buffer is to be used.
2.From the buffer equation, calculate the ratio of salt and
weak acid required to obtain the desired pH. The buffer
equation is satisfactory for approximate calculations
within the pH range of 4 to 10.
3.Consider the individual concentrations of the buffer salt
and acid needed to obtain a suitable buffer capacity.

A concentration of 0.05 to 0.5 M is usually sufficient, and


a buffer capacity of 0.01 to 0.1 is generally adequate.
4. Other factors of some importance in the
choice of a pharmaceutical buffer include:
• availability of chemicals
• sterility of the final solution
• stability of the drug and buffer on aging
• cost of materials and freedom from toxicity

For example: a borate buffer, because of its toxic


effects, certainly cannot be used to stabilize a
solution to be administered orally or parenterally.
5. Finally, determine the pH and buffer capacity of
the completed buffered solution using a reliable
pH meter.
• In some cases, sufficient accuracy is obtained by
the use of pH papers. Particularly when the
electrolyte concentration is high.
Or Buffered Isotonic Solutions
YPCRC/Ph.In.Chem./Unit 30
II
Measurement of tonicity
Haemolytic method

YPCRC/Ph.In.Chem./Unit 34
II
YPCRC/Ph.In.Chem./Unit 35
II
YPCRC/Ph.In.Chem./Unit 36
II
YPCRC/Ph.In.Chem./Unit 37
II
YPCRC/Ph.In.Chem./Unit 38
II
YPCRC/Ph.In.Chem./Unit 39
II
Find the proportion of Dextrose required to
make a solution isotonic. The molecular weight
of dextrose is 180, and it is a non-ionizing
substance?
= 0.03 x 180 = 5.4g
Based on freezing point data/Cryoscopic method

• Blood plasma & lachrymal secretions have a freezing point


of -0.52 Co due to different solutes present in them.
• 0.9% NaCl solution also has freezing point aprox. -0.52
Co
• Hence, all solutions which freeze at this temperature will
be isotonic with these fluids.

Adjustment to the tonicity of solutions:


• If the freezing point of 1% solution whose tonicity is to be
adjusted is known.
• And freezing point of 1% solution of adjusting substance is
known.
•Tonicity of solution based on the freezing point
data calculated from the general formula

• a = freezing point of 1% solution of un-adjusted


solution
• b = freezing point of 1% solution of adjusting
solution

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