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ISSN 0975-234X
Research Journal of Pharmaceutical ABSTRACT:
Dosage Forms and Technology. 5(2):
The proper design and formulation of a dosage form requires consideration
March- April, 2013, 51-55
of the physical, chemical and biological characteristics of all of the drug
substances and pharmaceutical ingredients to be used in fabricating the
product. The drug and pharmaceutical materials utilized must be compatible
with one another to produce a drug product that is stable, efficacious,
attractive, easy to administer and safe. The product should be manufactured
under appropriate measures of quality control and packaged in containers
that contribute to product stability. The product should be labeled to
promote correct use and be stored under conditions that contribute to
Review Article maximum shelf life.
Methods for the preparation of specific types of dosage forms and drug
delivery systems are described in subsequent chapters. This chapter presents
some general considerations regarding pharmaceutical ingredients, drug
product formulation, and standards for good manufacturing practice.
INTRODUCTION:
Suspensions are an important category of pharmaceutical formulation and
present many challenges to formula development personnel because of their
inherent instability of structure and manufacturing and packaging problems.
Suspensions may be meant for oral administration, external application or
parenteral use. They generally consist of a finely divided solid (individual
particles ranging in size from 0.5 to 5.0µ) suspended in a liquid or semi-solid
*Corresponding Author: vehicle which constitutes the continuous phase. Many suspensions are these
Praneta Desale days marketed as dry powders which are ‘constituted’ before use by
Ph. D. Scholar, incorporation of specified amounts of a vehicle. Such ‘suspensions’ are
Department of Pharmacy, produced mainly on account of considerations of stability.
CMJ University, Shillong,
Meghalaya -793003, India. The particle size of the disperse phase is a very important consideration in
suspension formulation. Suspensions for topical application should have
very small particle size to avoid a gritty feel on application and to provide
greater coverage and protection to the area to which the suspension is
applied. In case, the solid substance is meant for skin penetration, its small
size will give a quicker rate of dissolution and hence of the penetration. In
suspensions, meant for introduction into the ophthalmic cavity, the particle
size should not go beyond 10µ. Below this size the patient feels no pain but
above this the suspension may give a feeling of pain or discomfort.
Received on 15.03.2013 Injectable suspensions should have a particle size that can easily pass
Modified on 25.03.2013 through the syringe needle. The needle shaped particles generally give a
Accepted on 02.04.2013
sustained action and hence are preferable in ‘depot’ type products.1
© A&V Publication all right reserved
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Research J. Pharma. Dosage Forms and Tech. 2013; 5(2): 51-55 Praneta Desale
phosphate. The physical stability of the system is PREPARATION OF SUSPENSIONS FORM DRY
enhanced by addition of carboxymethylcellulose, Carbopol POWDERS AND GRANULES FOR
934, veegum, tragacanth or bentonite either alone or in RECONSTITUTION
combination. No physical incompatibility is recorded as Suspensions may be prepared from previously
majority of hydrophilic colloids are negatively charged manufactured dry powders or granules if the liquid
and are compatible with anionic flocculating agents. When preparation has a limited shelf life because of chemical or
a flocculated suspension of negatively charged particles physical instability. Powders should firstly be loosened
with a cationic electrolyte is prepared (aluminum chloride) from the bottom of the container by lightly tapping against
the addition of hydrocolloid may result in an incompatible a hard surface. The specified amount of cold, purified
product resulting in stingy mass, which has no suspending water should then be added, some times in two or more
action, and settle rapidly. In such a condition protective portions, with shaking, until all the dry powder is
agent is added to change the sign on the particles from the suspended. The container is usually over-sized in order to
negative to positive is employed which can also be allow adequate shaking for reconstitution. Some
achieved by the adsorption onto the particle surface by suspensions may be prepared by the patient immediately
fatty acid amine or gelatin. Thus an anionic electrolyte is before taking from individually packed sachets of powder
used to produce floccules that are compatible with or from bulk solids.
negatively charged suspending agent. 9
CONTAINERS FOR SUSPENSIONS
QUALITY CONTROL TESTS FOR SUSPENSIONS Suspensions should be packed in amber bottles, plain for
Sedimentation volume internal use and ribbed for external use. There should be
Redispersibility is the major consideration in adequate air space above the liquid to allow shaking and
assessing the acceptability of a suspension. The ease of pouring. A 5 ml medicine spoon or oral syringe
measurement of the sedimentation volume and its should be given when the suspension is for oral use
ease of redispersion form two of the most common
basic evaluative procedures. The sedimentation SPECIAL LABELS AND ADVICE FOR
volume is the simple ratio of the height of sediment to SUSPENSIONS
initial height of the initial suspension. The larger the The most important additional label for suspensions is
value better is the suspendability. ‘Shake well before use’, as some sedimentation of
medicament would normally be expected. Shaking the
Particle size and size distribution bottle will redisperse the medicament and ensure that an
The freeze-thaw cycling technique used to assess accurate or aliquot does can be measured by the patient.
suspension for stress testing for stability testing result
in increase of particle growth and may indicate future “Store in a cool place.’ Stability of suspensions may be
state after long storage. It is of importance to study adversely affected by extremes and variations of
the changes for absolute particle size and particle size temperature. Some suspensions, such as those made from
distribution. It is performed by optical microscopy, reconstituting dry powders, may need to be stored in the
sedimentation by using Andreasen apparatus and refrigerator.
Coulter counter apparatus, none of these methods are
direct methods. The sedimentation method yields a Extemporaneously prepared and reconstituted suspensions
particle size relative to the rate at which particles will have a relatively short shelf life. They are usually
settle through a suspending medium. required to be recently or freshly prepared, with a 1-4
week expiry date. Some official formulae state an expiry
Rheological studies date, but many do not. The pharmacist may have to make
Rheologic methods can help in determining the judgments about the expiry date for a particular
settling behaviour of the suspension. Brookefield preparation, based on its constituents and likely storage
viscometer with variable shear stress control can be conditions. The manufacturer’s literature for reconstituted
used for evaluation viscosity of suspensions. It products will give recommended storage conditions. 11,12
consist of T-bar spindle which is lowered into the
suspension and the dial reading is noted which is a CONCLUSION:
measure of resistance the spindle meets at various This paper will consider how suspensions can best be
levels in the suspension. This technique also evaluated to see how well they meet the purpose for which
indicates in which level of the suspension the they were designed. The performance check of
structure is greater due to particles aggregates. Data suspensions will not be reviewed from the standpoint of
obtained on aged and stored suspension reveals the control chemist who is following a standard set of
whether changes have taken place. 10 procedures on a series of production samples and whose
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Research J. Pharma. Dosage Forms and Tech. 2013; 5(2): 51-55 Praneta Desale
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