It contains basic information about dry syrup.

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DRY SYRUPDRY SYRUP
AZAD COLLEGE OF PHARMACYAZAD COLLEGE OF PHARMACY
Prakash chandra DashPrakash chandra Dash

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DefinitionDefinition
• Dry syrups are powder mixtures thatDry syrups are powder mixtures that
require the addition of waterrequire the addition of water
(reconstitution) at the time of dispensing(reconstitution) at the time of dispensing
and are mostly for pediatric use. Theseand are mostly for pediatric use. These
are called dry powders for oral suspensionare called dry powders for oral suspension
or reconstitutable oral suspensions.or reconstitutable oral suspensions.

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objectivesobjectives
1.Inadequate chemical stability of the drug in the1.Inadequate chemical stability of the drug in the
aqueous vehicle.aqueous vehicle.
2.Avoid the physical stability problems like2.Avoid the physical stability problems like
viscosity changes, conversion of polymorphicviscosity changes, conversion of polymorphic
form, incompatibility, crystal growth, caking.form, incompatibility, crystal growth, caking.
3.Reduces the weight of final product.3.Reduces the weight of final product.

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characteristicscharacteristics
• Power blend must be a uniform mixture of thePower blend must be a uniform mixture of the
appropriate concentration of each ingredients.appropriate concentration of each ingredients.
• During reconstitution the powder blend mustDuring reconstitution the powder blend must
disperse quickly and completely in aqueousdisperse quickly and completely in aqueous
vehicle.vehicle.
• It must be easily redispersed and poured by theIt must be easily redispersed and poured by the
patient to provide accurate and uniform dose.patient to provide accurate and uniform dose.
• Final product must have an acceptableFinal product must have an acceptable
appearance , odor and taste.appearance , odor and taste.

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FormulationFormulation
1.Suspending agent 2.Wetting agent1.Suspending agent 2.Wetting agent
3.Preservatives 4.Sweeteners3.Preservatives 4.Sweeteners
5.Flavor 6.Buffer5.Flavor 6.Buffer
7.Color 8.Anticaking7.Color 8.Anticaking
agentagent
9.Flocculating agent 10.Solid diluent9.Flocculating agent 10.Solid diluent
11.Antifoaming agent 12.Granule binder11.Antifoaming agent 12.Granule binder
13.Granule disintegrant 14.Antioxidant13.Granule disintegrant 14.Antioxidant
15.Lubricant15.Lubricant

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Suspending agentSuspending agent
• These are used toThese are used to prevent sedimentation.prevent sedimentation.
• Eg: methyl cellulose, carboxymethylEg: methyl cellulose, carboxymethyl
cellulose , hydroxyethyl cellulose , HPMC ,cellulose , hydroxyethyl cellulose , HPMC ,
polyvinyl pyrrolidone , poloxamer ,polyvinyl pyrrolidone , poloxamer ,
guargum etc.guargum etc.

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Wetting agentWetting agent
Wetting agents Wetting agents are chemical substances thatare chemical substances that
increase the spreading and penetratingincrease the spreading and penetrating
properties of a liquid by lowering its surfaceproperties of a liquid by lowering its surface
tension - that is, the tendency of its molecules totension - that is, the tendency of its molecules to
adhere to each other at the surface.adhere to each other at the surface.
Eg: polysorbate 80 , polysorbate 40 , sorbitanEg: polysorbate 80 , polysorbate 40 , sorbitan
monolaurate , sorbitan monooleate , poloxamermonolaurate , sorbitan monooleate , poloxamer
188 , sorbitan monosterate etc.188 , sorbitan monosterate etc.

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preservativespreservatives
• Substances which check or control theSubstances which check or control the
microbial growth.microbial growth.
• Eg: sucrose in sufficient concentrationEg: sucrose in sufficient concentration
(60% w/w) , sodium benzoate.(60% w/w) , sodium benzoate.

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sweetenerssweeteners
• Sweeteners can the mask the unfavorableSweeteners can the mask the unfavorable
taste and enhance patient acceptance bytaste and enhance patient acceptance by
giving sweet taste to the product.giving sweet taste to the product.
• Eg: sucrose , mannitol , dextrose ,Eg: sucrose , mannitol , dextrose ,
aspartame , sodium saccharin.aspartame , sodium saccharin.

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flavorflavor
• Flavoring agents are use for increase theFlavoring agents are use for increase the
patient compliance by increase the tastepatient compliance by increase the taste
and decrease / mask the bad odor of theand decrease / mask the bad odor of the
formulation.formulation.
• Eg: raspberry , pineapple etc.Eg: raspberry , pineapple etc.

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Buffering agentBuffering agent
• These are used to maintain the pH of theThese are used to maintain the pH of the
product.product.
• Eg: citrate , gluconates , lactates etc.Eg: citrate , gluconates , lactates etc.

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AntioxidantAntioxidant
• These are used maintain product stabilityThese are used maintain product stability
by being oxidized.by being oxidized.
• Eg: Butylated Hydroxy Toluene (BHT) ,Eg: Butylated Hydroxy Toluene (BHT) ,
Butylated Hydroxy Anisole (BHA) ,Butylated Hydroxy Anisole (BHA) ,
ascorbic acid etc.ascorbic acid etc.

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Anticaking agentsAnticaking agents
• An An anticaking agentanticaking agent is an additive placed in is an additive placed in
powdered or granulated materials, to prevent thepowdered or granulated materials, to prevent the
formation of lumps (formation of lumps (cakingcaking) and for easing) and for easing
packaging, transport and consumption.packaging, transport and consumption.
• Eg: calcium aluminum silicate , calciumEg: calcium aluminum silicate , calcium
phosphate tribasic , calcium silicate , calciumphosphate tribasic , calcium silicate , calcium
stearate , magnesium carbonate , magnesiumstearate , magnesium carbonate , magnesium
silicate , magnesium oxide , MCC etc.silicate , magnesium oxide , MCC etc.

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Flocculating agentsFlocculating agents
• Flocculants, or Flocculants, or flocculating agentsflocculating agents (also (also
known as flocking known as flocking agentsagents), are chemicals that), are chemicals that
promote promote flocculationflocculation by causing colloids and by causing colloids and
other suspended particles in liquids toother suspended particles in liquids to
aggregate, forming a floc. Flocculants are usedaggregate, forming a floc. Flocculants are used
in water treatment processes to improve thein water treatment processes to improve the
sedimentation or filterability of small particles.sedimentation or filterability of small particles.
• Eg: silica , bentonite , alum, ferric hydroxide etc.Eg: silica , bentonite , alum, ferric hydroxide etc.

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Antifoaming agentsAntifoaming agents
• A defoamer or an A defoamer or an antianti--foaming agentfoaming agent is is
a chemical additive that reduces anda chemical additive that reduces and
hinders the formation of hinders the formation of foamfoam in process in process
liquids.liquids.
• Eg: algenates , mineral oil , acepol 100Eg: algenates , mineral oil , acepol 100
etc.etc.

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Coloring agentsColoring agents
• A color additive is any dye, pigment orA color additive is any dye, pigment or
substance which when added to a food,substance which when added to a food,
drug or cosmetic, or to the human bodydrug or cosmetic, or to the human body
will impart a color.will impart a color.
• Eg: amaranth , tartrazine , erythrosine etc.Eg: amaranth , tartrazine , erythrosine etc.

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Formulation of Ambroxol HclFormulation of Ambroxol Hcl
& Azithromycin dry syrup& Azithromycin dry syrup
IngredientsIngredients F1F1 F2F2 F3F3
AzithromycinAzithromycin 44 44 44
Ambroxol HclAmbroxol Hcl 0.60.6 0.60.6 0.60.6
AcaciaAcacia 10.010.0 5.05.0 ……....
Sodium CMCSodium CMC ………… ………… 6.06.0
SSGSSG 1.01.0 1.01.0 1.01.0
SucroseSucrose 45.845.8 50.850.8 49.849.8
Sodium benzoateSodium benzoate 0.20.2 0.20.2 0.20.2
Banana flavorBanana flavor q.sq.s q.sq.s q.sq.s
Purified water q.s. toPurified water q.s. to 100100 100100 100100

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preparationpreparation
Preparation of dry mixer:Preparation of dry mixer:
1.Powder blends1.Powder blends
2.Granulated product2.Granulated product
3.Combination product3.Combination product

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Powder blendsPowder blends
• MixingMixing the ingredients of the dry mixture inthe ingredients of the dry mixture in
powder form.powder form.
• Ingredients present inIngredients present in small quantitiessmall quantities maymay
require accending order mixing operation.require accending order mixing operation.
• Mixture shouldMixture should rapidly and reliablyrapidly and reliably produce aproduce a
homogeneous mixturehomogeneous mixture..

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advantagesadvantages
• Least capitalLeast capital equipment and energy.equipment and energy.
• LeastLeast likely to havelikely to have chemical and stabilitychemical and stability
problemsproblems because no heat or solvents arebecause no heat or solvents are
used.used.
• Low moisture contentLow moisture content can be achieved incan be achieved in
dry mixture.dry mixture.

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disadvantagesdisadvantages
• HomogeneityHomogeneity problems – Particle size andproblems – Particle size and
Powder flow.Powder flow.
• LossLoss of the active ingredient duringof the active ingredient during
mixing.mixing.
• Potent drug used in veryPotent drug used in very lowlow
concentrations.concentrations.

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Granulated productsGranulated products
• Wet granulationWet granulation is the usual process and granulating fluid isis the usual process and granulating fluid is
water or an aqueous/non aqueous binder solution.water or an aqueous/non aqueous binder solution.
• Drug can beDrug can be dry blendeddry blended with other ingredients or it can bewith other ingredients or it can be
dissolved or suspendeddissolved or suspended in the granulating fluid.in the granulating fluid.
• Solid ingredients areSolid ingredients are blended and massedblended and massed with granulating fluid in awith granulating fluid in a
planetary mixer.planetary mixer.
• Wet massWet mass is formed into granules : Vibratory sieve, Oscillatingis formed into granules : Vibratory sieve, Oscillating
granulator or millgranulator or mill
• Granules driedGranules dried in a tray oven or Fluid bed drier.in a tray oven or Fluid bed drier.
• Dried granulesDried granules screenedscreened in a vibratory sieve or oscillating granulatorin a vibratory sieve or oscillating granulator
to break up or remove aggregates or granules.to break up or remove aggregates or granules.

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advantagesadvantages
• Improved appearance.Improved appearance.
• Improved flow characteristics.Improved flow characteristics.
• Less segregation problems.Less segregation problems.
• Less generation of dust during fillingLess generation of dust during filling
operations.operations.

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disadvantagesdisadvantages
• More capital equipment and energy.More capital equipment and energy.
• Uniform granulation is necessary.Uniform granulation is necessary.

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EvaluationEvaluation
• (1) Flow properties:
• (2) Rheological behavior:
• (3) Sedimentation behavior:
• (4) Drug content:
• (5) In vitro drug release:
• (6) Particle size:
• (7) Viscosity:
• (8) Zeta potential measurement:
• (9) Stability study:
• 10) PH values:

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EvaluationEvaluation
• (1) Flow properties: Flow properties
such as angle of repose, bulk density, tap
density etc. should be carried out.
• (2) Rheological behavior: The
rheological behavior of the dry syrup is
determined using Brookefield viscometer .

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Evaluation cont…..Evaluation cont…..
• (3) Sedimentation behavior:-a)
Redispersibility: The redispersibility is
determined by studying the number of
strokes to redisperse the formed sediment
at the end of 7 days of storage of the
formulations (not more than 100 strokes =
Redispersibility).

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Evaluation cont……Evaluation cont……
• b) Sedimentation Volume Ratio (SVR):
sedimentation volume of a suspension is
expressed by the ratio of the equilibrium volume
of the sediment, Vu, to the total volume, Vo of
the suspension. i.e. F=Vu/Vo The value of F
normally lies between 0 to 1 for any
pharmaceutical suspension. The value of F
provides a qualitative knowledge about the
physical stability of the suspension.

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Evaluation cont…..Evaluation cont…..
• (4) Drug content: The required weight
of drug mixture is taken and extracted with
100ml solvent and solution is filtered
through nylon filter membrane. 0.1ml of
the solution is further diluted to 10ml with
solvent and absorbance of the solution is
read on UV Spectroscopy. The drug
concentration is extrapolated from the
calibration curve in solvent.

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Evaluation cont……Evaluation cont……
• (5) In vitro drug release: The in vitro
dissolution studies were carried out using
USP apparatus Type II at 100 rpm. The
dissolution medium consisted of 900 ml
distilled water maintained at 370C ± 0.50
C. The drug release at different time
intervals was measured for two hours
using UV spectrophotometer.

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Evaluation cont…..Evaluation cont…..
• (6) Particle size: The dry syrup is
evaluated, the average particle size of the
formulation is examined using standard
microscopy method .

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Evaluation cont……Evaluation cont……
• (7) Viscosity: The rheological behavior
of the suspension is determined by using
Brookfield viscometer.

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Evaluation cont……Evaluation cont……
• (9) Stability study: The dry syrup is stored in
air tight amber colored glass bottles for 36 days
at 45°C and then reconstituted with distilled
water to make up the volume to 60 ml with
gentle shaking. The reconstituted suspension is
stored at 4°C, 25°C and 45°C for 15 days. The
reconstituted suspension stored at various
temperatures are evaluated after reconstitution
and after 7th and 15th day of reconstitution.

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Evaluation cont……Evaluation cont……
• 10) PH values: The pH of suspensions
was measured with the aid of a pH meter.

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Thank you so muchThank you so much