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Dry syrup

1. Dry syrups are powder mixtures that require the addition of water at dispensing and are for pediatric use. They avoid stability issues like changes in viscosity, polymorphism, and caking seen in aqueous suspensions. 2. A dry syrup formulation contains suspending agents, wetting agents, preservatives, sweeteners, flavors, buffers, colors, and other excipients. It must form a uniform mixture upon reconstitution with water. 3. Dry syrups can be prepared by mixing powder blends or granulating ingredients with a wet granulation process and drying the granules. This provides a stable formulation that is easily reconstituted for pediatric patients.

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11 DRY SYRUPDRY SYRUP AZAD COLLEGE OF PHARMACYAZAD COLLEGE OF PHARMACY Prakash chandra DashPrakash chandra Dash
2 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.
3 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.
4 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.
5 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
6 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.
7 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.
8 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.
9 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.
10 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.
11 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.
12 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.
13 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.
14 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.
15 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.
16 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.
17 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
18 preparationpreparation Preparation of dry mixer:Preparation of dry mixer: 1.Powder blends1.Powder blends 2.Granulated product2.Granulated product 3.Combination product3.Combination product
19 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..
20 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.
21 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.
22 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.
23 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.
24 disadvantagesdisadvantages • More capital equipment and energy.More capital equipment and energy. • Uniform granulation is necessary.Uniform granulation is necessary.
25 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:
26 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 .
27 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).
28 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.
29 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.
30 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.
31 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 .
32 Evaluation cont……Evaluation cont…… • (7) Viscosity: The rheological behavior of the suspension is determined by using Brookfield viscometer.
33 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.
34 Evaluation cont……Evaluation cont…… • 10) PH values: The pH of suspensions was measured with the aid of a pH meter.
35 Thank you so muchThank you so much