Powders and Granuleswhat

7/27/2019 Powders and Granuleswhat

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Powders and

GranulesUy, Orlando Louis

Villanueva, Berle Joy

Villespin, Vanessa Jae


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Powder

A dry substance

composed of finely

divided particles

A type of

pharmaceutical

preparation A medicated powder

intended for internal

or external use.


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PARTICLE SIZE AND

ANALYSIS

The particles of powders and

granules may range from being

extremely COARSE, about 10mm

(1cm) in diameter, to EXTREMELYFINE, approaching colloidal

dimensions of 1mcg or less.


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Characterization of USP

of powders

Very coarse, moderately

coarse, fine and very fine


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DESCRIPTIVE TERMS

VERY COARSE (No. 8) All particles pass through (No. 8) sieve and not more than 20 % pass through a No.

6 sieve

COARSE (No. 20) All particles pass through (No. 20) sieve and not more than 40 % pass through a No.

60 sieve

MODERATELY COARSE (No. 40) All particles pass through (No. 40) sieve and not more than 40 % pass through a No.

80 sieve

FINE (No. 60) All particles pass through (No. 60) sieve and not more than 40 % pass through a No.

100 sieve

VERY FINE (No. 80) All particles pass through (No. 80) sieve. There is no limit to greater fineness.


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SIEVES

Made of wire

cloth woven

from brass,bronze and

other suitablewire. Not

coated or


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POWDERS OF VEGETABLE

AND ANIMAL ORIGIN

DRUGS Granules 4 to 12 sieve size.

12 20 sieve range are sometimes

used in tablet making

(REFER TO THE TABLE, page 185)


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PURPOSE OF PARTICLE

SIZE ANALYSIS

To obtain quantitative data onthe size, distribution, and

shapes of the drug and other

components to be used in

pharmaceutical formulations.


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PARTICLE SIZE

INFLUENCES ON VARIETY

OF FACTORS: Dissolution rate of particles intended to dissolve

(smaller: increases rate of distribution and itsbioavailability)

Suspendability intended to remain undissolvedbut uniformly dispersed in a liquid vehicle (finedispersions: .5-10mcg)

Uniform distribution of a drug substance in a

powder mixture or solid dosage form ensuresDOSE TO DOSE CONTENT UNIFORMITY

Penetrability (to be inhaled for deposition deep inthe respiratory tract

Lack of Grittness of solid particles in semi-solid


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METHODS TO DETERMINE

PARTICLE SIZE SIEVING

MICROSCOPY

SEDIMENTATION

RATE

LIGHT ENERGY

DIFFRACTION ORLIGHT SCATTERING

LASER

HOLOGRAPHY


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Why Micrometrics is

important It is important because the physical

state of particles can be altered byphysical manipulation and particle

characteristics can alter

THERAPEUTIC EFFECTIVENESS Particle any unit of matter having

defined physical dimensions


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Comminution

of Drugs


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SMALL SCALE Example: pharmacist

reduced the size of adrug by grinding with amortar and pestle

(porcelain is betterthan glass mortar dueto its ROUGHSURFACE)

TRITURATION ORCOMMINUTION grinding a drug in amortar to reduce its

particle size.


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LARGE SCALE: Mills and pulverizers are

used.

Example of machine:FITZMILL COMMINUTINGMACHINE WITH APRODUCT CONTAINMENTSYSTEM.

It is grinded rapidly into amoving blades in thecomminuting chamber,particles are reduced in size

and it is passed through a


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The collection and

containment systemsrole:

Protects the environmentfrom chemical dust

Reduces product loss

Prevents product

contamination


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LEVIGATION for small scale

preparation ofointments and

suspensions to reducethe particle size andgrittiness of the addedpowders

Mineral oil and glycerinare commonly used aslevigating agents

(added to the powder


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BLENDING

POWDERS

When two or more powderedsubstances are to be combined to

form a uniform mixture, it is best

to reduce the particle size of eachpowder individually before

weighing and blending.

METHODS


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METHODS

USED FOR

BLENDING


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Trituration glass mortar is usually preferred ifthere is no special need for

comminution.


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Geometric Dilution the blending of a

small amount of

potent substancewith a large

amount of diluent.

It ensures uniformdistribution of the

potent drug.


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Tumbling

tumbling the powder in a rotatingchamber. Thorough but time

consuming. This is widely

employed in the industry


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Segregation undesirable separation of thedifferent components of the blend.

It may occur through sifting or

percolation, air entrapment

(fluidization) and particle

entrapment (dusting).


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MEDICATED

POWDERS can be use internally or externally

Powders taken orally for systemicuse may be expected to result in

faster rates of dissolution andabsorption than solid dosage

forms, because there is an

immediate contact with the gastric

DISADVANTAGE OF


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DISADVANTAGE OF

MEDICATEDPOWER

Undesirable taste of the


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AEROSOL POWDERS

Administered by inhalation with the aid of

dry-powder inhalers, which deliver

micronized particles of medication in

metered quantities.

Prepared in 1 to 6mcg in diameter

Contain inert propellants and

pharmaceutical diluents such as

CRYSTALLINE ALPHA-LACTOSE

MONOHYDRATE to aid the formulations

flow properties and metering uniformity


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Powder Blowers

(Insufflators) may be used todeliver dry powders

to various parts of the

body. Examples:lung, nose, throat

and vagina

Depression of thedevices rubber

bulb causes

turbulence of the

powder in the vessel,


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BULK POWDERSLimited to non-potent substances

Examples:

ANTACIDS (NaHCO3)

LAXATIVES (Psyllium)

DOUCHE POWDERS (Massengill

powder)

Topical Anti- Infectives (Bacitracin zinc etc)

Anti-fungals (tolnaftate)

Nutritional supplements (brewers yeast


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DIVIDED POWDERS Division into individual dosing

units based on the amount to be

take or used at a single time POWDER paper latin word

chartula abbrev: chart

Placed on a small piece of paper

that is folded to enclose the

medication.

WAYS ON HOW


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WAYS ON HOW

PHARMACISTS DIVIDE

POWDERS: (depending on the potency of thedrug substance)

1. Block-and-divide method (for non-potent drug)

put in a porcelain or glass plate

spatula

2. Weigh each portion separately


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Papers used for Divided Powers

Simple bond paper Vegetable parchment

(semi-opaque with

limited moistureresistance

Glassine (glazed

transparent, limitedmoisture resistance)

Waxed paper

transparent waterproof


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Waxed Paper - If the powder is

hygrosgopic or deliquescent

Bond Paper - For aesthetic appeal

Vegetable parchment and glassine

limited barrier against moisture isnecessary

Glassine or waxed paper containing

volatile components White bond paper containing

neither volatile components or

moisture


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(STEPS ON HOW TO MAKE

PAPER TABS page 195)

It should fit snugly in the box,

have uniform folds and be

uniform in length and height. There should be NO powder in

the folds None should escape with

moderate agitation


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GRANULES prepared agglomerates

of similar particles of

powder

most of the time

irregularly shaped but

may be prepared to be

spherical

usually 4- to 12-mesh

sieve size range


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WET METHOD Moisten the powder of powder

mixture and then pass the

resulting paste through a screenof the mesh size to produce the

desired size of granules. The

granules are placed on dryingtrays and are dried by air or under

heat. It is periodically moved


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FLUID BED

PROCESSING -

particles are placedin a conical piece of

equipment and are

vigorouslydispersed and

suspended while a

liquid excipient is

sprayed on the

particles and the

product dried,

forming granules or


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DRY GRANULATION

METHODS Dry powder is passed

through a roll compactorand then through agranulating machine. The

roll compactor processes afine powder into densesheets or forms by forcing itthrough 2 mechanicallyrotating metal rolls running

counter to each other. Thesurface of the compactingrolls may be smooth or mayhave pocket indentations orcorrugations that allow

compaction of different


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SLUGGING - the

compression of a powder

mixture into large tablets

or slugs on a

compressing machine

under 8000 to 12000 lbs

of pressure.


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The dry process often

results in the production

of fines, that is, powder

that has not

agglomerated intogranules. These are

separated collected and GRANULES AND ITS


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GRANULES AND ITS

CHARACTERISTICS: More stable to the effects of atmospherichumidity(due to its less surface area

compared to a volume of powder) and areless likely to harden upon standing

More easily wetted by liquids than are

certain light and fluffy powders. (which

tend to float on the surface)

Often preferred for dry products intended

to be constituted into solutions or

sus ensions


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Example of a drug that is

made into granules:Antibiotic drugs

since these areunstable inaqueous solution

(constituted withpurified water justprior to

dispensing)


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EFFERVESCENT

GRANULATED SALTS Granules are coarse to very coarse powders containinga medicinal agent in a dry mixture usually composed of

NaHCO3, citric and tartaric acid.

When added to H20, the acids and base react toliberated CO2, resulting effervescence

Resulting carbonated solutions masks undesirable taste

of any medicinal agent.

Using granules or coarse particles decreases the rate ofsolution and prevents violent and uncontrollable

effervescence

Effervescence could overflow the glass and leave

residual carbonation in the solution


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TARTATIC ACID

alone granuleslose its firmness

and crumble

CITRIC ACID alone

results in a stickymixture difficult to

granulate


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PROCESSES


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DRY METHOD or

FUSION METHOD Citric acid crystals are powdered and then mixedwith the other powders of the same sieve size toensure uniformity of the mixture

Sieves and mixing equipment should be madeSTAINLESS STEEL or other material resistant tothe effect of the acids

The mixing is performed as rapidly as is practical

Preferably in a low environment humidity to avoidabsorption of moisture and a premature chemicalreaction

After mixing, it is placed in an oven and an acid-resistant spatula is used to turn the powder

As it became spongy after heating, it is now


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WET METHOD It differs from the fusion method in that the

source of binding agent is not the water ofcrystallization from the citric acid but the

water added to alcohol as the moisteningagent, forming the mass of granulation.

All of the powders may be ANHYDROUSEas long as water is added to the

moistening liquid.

Just enough liquid is added (in portions) toprepare a mass of proper consistency until

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