1

FORMULATION AND FORMULATION AND MANFACTURE OF MANFACTURE OF

POWDERSPOWDERS

2

CONTENTS

• Powders definition

• Classification of powders

• Powders for external use

• Powders for internal use

• powders manufacture

• Powders as inhalation dosage foams

3

Powders are sub divided solids which are classified in the B.p. according to the size of the constituent particles which range from <1.25mm to 1.70mm diameter

4

Advantages of powders:Advantages of powders:

• Good chemical stability compared with fluids• Useful for bulky drugs with large dose, e.g.

indigestion powder. • Easy to swallow even in large bulk, especially if

mixed with drink food (useful for stomach- tube feeding)

• The smaller particle size of powders causes more rapid dissolution in body fluids, increases drug bioavailability, and decreases gastric irritation compared with tablets

•

5

Disadvantages of PowdersDisadvantages of Powders• Not suitable for drugs unstable in atmospheric

conditions • Not suitable for bitter, nauseating, deliquesnt and

corrosive drugs.• Inaccuracy of dose in case of bulk powder• Inconvenient to carry.

6

CLASSFICATIONCLASSFICATION OF POWDERS OF POWDERS Powders are classified according to manner of their dispensing

1.Bulk powders for external use

2.Bulk powders for internal use

3.Siple and compound powders for internal use

4.Effervesent granules

5.Cachets

7

POWDERS FOR EXTERNAL USE • Bulk powders are used as external application, In this

dusting powders ,snuffs, douche powders, dental powders, insufflations are included.

• These powders contain non potent substances for external application

DUSTING POWDERS : These are the dry of mass of pulverized , or

finely dispersed solid particles for spreading on the body

8

• In this two types (a) medical, (b)surgicalMEDICAL DUSTING POWDERS• Used for superficial skin conditions• These mainly contain zinc oxide, boric acid, or natural mineral• substances like kaolin• Talc may be contaminated with Spores of tetanus, and, anthrax• So , sterrilised by heat.• Not apply to broken skin ,open wounds

9

SURGICAL POWDERS

• Powders are used in body cavities and major wounds, on burns

• Must be sterile

• These contain an anti microbial agent and diluent may be sterilisable starch

• Known as absorbable dusting powder in chlorhexidine,

hexachlorophane

10

FORMULATION OF DUSTING POWDERFORMULATION OF DUSTING POWDER

FORMULATION Dusting powder

zinc undecenoate 100g 5.0g

Undecenoic acid 20g 1.0g

pumilio pine oil 5ml 0.25ml

starch in powder 500g 25.0g

light kaolin, sterilised 1000g up to 50g

11

METHOD

• Measure the oil in ml pipette and transfer in to glass mortar

• At above 20° c undecenoic acid is liquid weigh it

• Mix with the oil

• Mix the undeeonoate gradually increasing amounts starch and

light kaolin adsorbate alternately to incorporate the rest of kaolin

• sieve and remix lightly

12

DENTAL POWDERS

• It is a type of dentifrice meant for cleaning the teeth

• These powders contain detergents, abrasives, antiseptics, and flavouring agents incorporated in a suitable base.

• Generally calcium carbonate is suitable base

13

FORMULATION OF DENTAL POWDERSFORMULATION OF DENTAL POWDERS

Type of preparation Dentifrice Hard soap 50 g Precipitated 935gm calcium carbonate Saccharin sodium 2gm Peppermint oil 2ml Cinnamon oil 2ml Methyl salicylate 8ml

14

METHOD• triturate the saccharin sodium • The oil and methyl salicylate with one half

precipitated calcium carbonate • Mix the soap with remaining calcium carbonate• Mix two powders thoroughly and then pass it through

a fine sieve• Essential oils to provide a flavour ,freshness to the

mouth, antiseptic action

15

DOUCHE POWDERS • These powders are completely soluble and intended to be

dissolved in water used as antiseptics, cleansing agents for a body cavity

• Most commonly used for vaginal ,otic, opthalamic use also• The formulation contain aromatic oils ,it necessary pass

through sieve #40 or 60 to eliminate agglomerisation and to ensure complete mixing

• To use add the prescribed powders inappropriate volume of warm water and stirs until dissolovd

16

Components:

1. Boric acid or Borax

2. Astringents as K alum, ammonium alum, ZnSO4

3. Antimicrobial as oxyquinoline sulfate or povidone iodine

4. Quaternary ammonium compounds as benzethonium chloride

5. Detergents as sodium lauryl sulfate

6. Oxidizing agents as sodium perborate

7. Salts, as sodium citrate, sodium chloride

8. Aromatic as menthol, thymol, eucalyptol, methyl salicylate, and phenol

17

18

STEPS STEPS in in PREPARING PREPARING POWDERSPOWDERS

Particle Particle size size

reductioreductionn

Mixing of Mixing of PowdersPowders

Packaging Packaging

of of PowdersPowders

19

Particle Size Reduction

Comminution or grinding may be defined as the process of particle size reduction

20

METHODS OF COMMINUTION IN SMALL SCALEMETHODS OF COMMINUTION IN SMALL SCALE

Trituration - Is the process of grinding a powder in a mortar and pestle to reduce its particle size.

Pulverization by Intervention - Is the reduction of particle size with the aid of a second agent which can be readily removed from the pulverized product

Example: applies to camphor where it is readily triturated when a few drops of alcohol or other volatile solvent is added. The pulverized camphor is

readily recovered as the solvent evaporates.

Levigation - Is the process of reducing particle size by first forming a paste of the solid with a minimum amount of a levigating agent and then triturating the paste in a mortar or on slab with a spatula.

21

The Basis of Choice of Levigating Agent is:

1.Its ability to form a smooth paste with the substance

2.Its compatibility in the product so water cannot be used for levigating a substance for oleaginous ointment base

22

SIEVE SIEVE SIEVE SIEVE

NUMBER OPENING NUMBEROPENING

2.0 9.50 mm 70.0212.00 um

3.5 5.60 mm 80.0180.00 um

4.0 4.75 mm 100.0 150.00 um

8.0 2.36 mm 120.0 125.00 um

10.0 2.00 mm 200.0 75.00 um

20.0 850.00 um 230.0 63.00 um

30.0 600.00 um 270.0 53.00 um

40.0 425.00 um 325.0 45.00 um

50.0 300.00 um 400.0 38.00 um

60.0 250.00 um

OPENING OF STANDARD SIEVES

23

MANFACTURE OF POWDERS

MIXING OF POWDERS

• It depends on the nature of the ingredient ,the amount of powder to be prepared ,equipment available

• The equipment is two types small scale and large scale

• In small scale spatulation , trituration process are used.

24

SpatulationSpatulation• In spatulation method the small amounts of powder may be blended by a

spatula on a sheet of paper or pill• This also applied to solid substances which liquefy or to form eutectic

mixtures • Examples :phenol, camphor, menthol, thymol phena acetin ,

• Trituration• It is employed both to comminute and mix the powders using• a mortar with rough inner surface• in case of small amounts of potent substance to mixed with

a large amount of diluent ,a general method known as • “geometric dilution” is employed to a uniform mix•

25

The large scale Mixing euqipmentThe large scale Mixing euqipment Two types (1) Rotating shell mixers or Tumbilng type blendres, (2)Fixed shell mixers. Rotating shell type or tumbling type blenders : Drum type Cubical shaped Double cone Twin –shell blenders are used

26

DRUM TYPE BLENDERS

• In this the drum rotates with their axis horizontal to the center of drum

• These suffer from poor cross flow along the axis

• This problem is over come by addition of baffles or inclining the drum on it’s axis increases cross flow and improves the mixing action

27

Cubical and poly hedron shaped Cubical and poly hedron shaped blenderblender

• The rotating axis set various angels are available

• Their flat surfaces, the powder is subjected to more sliding

than a rolling action so this type of action efficient mixing is not possible

28

DOUBLE CONE BLENDERDOUBLE CONE BLENDER

• It is developed on the basis of to over come the draw backs of drum type ,cubical type blenders

• The mixing pattern provides a good cross flow with rolling rather than sliding motion

• No baffles are required So cleaning is easy

29

TWIN SHELL BLENDERSTWIN SHELL BLENDERS

• These are developed by combine the efficiency of inclined drum type with inter mixing it happen when two such mixers combine their flow.

Example

Patterson Kelly cross flow blender Twin shell blender

• In this blender even length of each shell provides additional mixing action• During each revolution the powder bed

combines

30

Fixed shell mixersFixed shell mixersIn this two types (a) Ribbon type (b) Sigma-blade planetary paddle mixer

RIBBON MIXER

• It is oldest mechanical solid solid mixing • It consists of long trough with semicircular

bottom• The shell is fitted with a shaft on which Spiral ribbons ,paddles ,helical screws, (Alone or in combination) mounted

31

• In this the mixing blades produces continous cutting and shuffling of charge by circulating the powder form

end to end of the trough as well as rotationally

• The shearing is developed between moving blade and trough

Disadvantages

these are not precision blenders ,difficult to clean ,

high requirement powder

32

SIGMA –BLADE AND PLANETRY PADDLE MIXERS

• Here addition development is introduction of liquids

• With high speed impellers blades set into the bottom of a vertical or cylindrical shell it shows efficient blending

• In this the agglomerates are break down rapidly by precise blends

• The disadvantage is mechanical heat is produced with in the powder bed,and high powder requirement

• But short interval over come these problems.

33

34

Powders are sub

divided solids which are classified in the B.p. according to the size of the constituent particles which range from <1.25mm to 1.70mm diameter

35