Pharmaceutical Powders – PST06103 Pharmaceutical Production

NTA Level 6 • Semester 1 • PST06103

Pharmaceutical Powders

Pharmaceutical Production • Source Session/Topic 8
Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 8: Pharmaceutical Powders

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define powders
• Explain the production of powders
• Classify powders
• List uses of powders in pharmacy
• List advantages and disadvantages of powders

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board and chalk/whiteboard markers
• LCD projector and computer

SESSION OVERVIEW

|Step |Time |Activity/ |Content |

| | |Method | |

|1 |05 minutes|Presentation|Introduction, Learning Tasks |

|2 |15 minutes|Brainstormin| Introduction to Powders |

| | |g | |

| | |Presentation| |

|3 |10 minutes|Presentation|Production of Powders |

|4 |30 minutes|Presentation|Preparation and Mixing of Powders |

|5 |30 minutes|Presentation|Bulk and Divided Powders |

|6 | |Small group |Advantages and Disadvantages of |

| |20 minutes|discussion |Powders |

| | |Presentation| |

|7 |05 minutes|Presentation|Key Points |

|8 |05 minutes|Presentation|Evaluation |

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Introduction to Powders (15 minutes)

|Activity: Brainstorming (5 minutes) |

| |

|ASK students to brainstorm on the following question: |

| |

|What is a pharmaceutical powder? |

| |

|ALLOW few students to respond? |

| |

|WRITE their responses on the flip chart/ board |

| |

|CLARIFY Al,0.++23.2+0000.nd SUMMARISE by using the content below |

• A pharmaceutical powder is a mixture of finely divided drug and /or

chemicals in dry form intended for internal or external use.

• Powders are intended to be used as;

o Dosage forms e.g. dusting powders

o Starting materials for other dosage forms e.g. tablets and capsules

▪ They determine behavior of dosage forms during manufacturing and

in the finished dosage form

▪ Particle size, density and porosity are important characteristic

of powders

• These affect the ability of powders to flow (flowability)
▪ Flowability may be measured by using the angle of repose
• Powders as dosage forms can be classified according to;

o Number of constituents

▪ Simple powders i.e. powders containing only one ingredient
▪ Compound powders i.e. powders containing two or more substances

mixed together

o Mode of application

▪ Powders for internal use
▪ Powders for external use

o Packaging

▪ Bulk powders
▪ Divided powders

STEP 3: Production of Powders (10 minutes)

• Molecular aggregation

o Precipitation

▪ Through super-saturation of solutions

o Crystallization

▪ Through super cooling of solutions

o Spray-drying

▪ Atomization of solution followed by evaporation of solvent
• Particle size reduction

o By use of equipment such as course crushers, grinders, and mills

STEP 4: Preparation and Mixing of Powders (30 minutes)

• Preparation of powder dosage forms

o Preparation of powders involves

o Particle size reduction (all ingredients) to the same range in order

to prevent demixing or segregation

➢ Trituration (using mortar and pestle)

➢ Pulverization by intervention (for gummy or materials difficult

to grind)

➢ Levigation

o Sieving

o Weighing of each ingredient

o Mixing

o Packaging

• Mixing of Powders

o Mixing is as an operation in which two or more components in a

separate or roughly mixed condition are treated so that each particle

lies as nearly as possible in contact with a particle of each of the

other ingredients

o For mixing to occur the individual particles must be redistributed

repeatedly within the bulk, either by tumbling, shearing, scooping,

kneading or impaction.

o Powders are mixed to obtain homogeneity. Equipment used for mixing are

known as mixers

o For small scale mixing e.g. in compounding, equipments used for mixing

are;

▪ mortar and pestle
▪ spatula and tile or paper
▪ sieving equipment (sieving)

o For large scale mixing e.g. in industrial production, large mixers

including

➢ tumbler mixers,

➢ shear mixers,

➢ ribbon mixers,

➢ impact mixers etc are employed

▪ Characteristics of an ideal mixer
• Capable of producing complete blend in reasonable time without damaging

the product

• Dust-tight
• Requiring low maintenance and energy
• Discharged and cleaned easily (All these properties cannot be found in a

single mixer)

o Methods used in mixing powders

▪ Spatulation
▪ Trituration (for both comminution and mixing)
▪ Geometric dilution
▪ Sifting
▪ Tumbling
• Types of powder mixtures

o Free flowing mixtures

o Cohesive mixtures

o Ordered mixtures

o Packaging of Powders

▪ Packed depending on use;
▪ Bulk powders
▪ Divided powders

STEP 5: Bulk and Divided Powders (30 minutes)

Bulk powders

• Bulk powders are limited to non potent drugs
• They are packed into suitable bulk containers to facilitate dosing (e.g.

wide mouth jar, perforated or sifter top cans and aerosol containers)

• Examples for powders commonly dispensed in a bulk form

o Powders used in a dry form e.g. dusting powders, insufflations,

dentifrices

o Powders to be dissolved in water before use e.g. antacid powders,

douche powders

o Powders for reconstitution e.g. oral antibiotic powders, powders for

injection (powders for injection may also be supplied as divided

powders)

• Bulk powders are classified into bulk powders for internal use and bulk

powders for external use

o Bulk Powders for Internal Use

▪ Contain several doses
▪ Dispensed in bulk
▪ Bulk powders for (oral) internal use are generally supplied as

finely divided powders or effervescent granules

• The finely divided powders are intended to be suspended or dissolved in

water or mixed with soft foods, e.g., applesauce, prior to administration

▪ They include; antacid powders, oral antibiotic powders, laxative

powders

o Oral Powders

▪ These generally are supplied as finely divided powders or

effervescent granules

▪ Granules are aggregates of powdered materials as a dosage form or for

making tablets or capsules (because of better flowability of granules

compared to powders)

o Oral powders are finely divided powders or effervescent granules

intended to be suspended or dissolved in water or mixed with soft

foods, e.g. applesauce, prior to administration

• Contain sodium bicarbonate and either citric acid, tartaric acid or

sodium biphosphate in addition to the active ingredients

• On solution in water, carbon dioxide is released as a result of the acid-

base reaction

• The effervescence from the release of the carbon dioxide serves to mask

the taste of salty or bitter medications.

• The completed product must be dispensed in tightly closed glass

containers to protect it against the humidity of the air

Examples of oral powders are antacids and laxative powders

o Bulk Powders for External Use

▪ Supply non potent drugs
▪ Powders dispensed in cardboard, plastic or glass containers, also

in sifter top containers

Classes of Bulk powders for External Uses

• Dusting powders
▪ They are used for external application on the skin and applied in a

very fine state of subdivision to avoid local irritation

▪ Dusting powders contain two or more ingredients one of which must be

either starch, kaolin or talc are used in the formulation

o Talc and kaolin are commonly used because they are chemically inert

o Dusting powders are applied to various parts of the body as

lubricants, protective, absorbents, antiseptics, anti-pruritics, anti-

bromhidrosis agents, astringents and antiperspirants

Characteristics of Dusting Powders

• Homogenous and very fine
• Free from irritation
• Flow easily
• Good covering capacity
• Good absorptive and adsorptive capacity
• Spread uniformly over body surface
• Cling to skin surface after application
• Protect skin from irritation caused by friction, moisture and chemical

irritants

Types of Dusting Powders

• Medical dusting powders

o They are for superficial skin conditions and for antiseptic, anti-

pruritic, astringent, antiperspirant, absorbent, protective and

lubricant purposes e.g. zinc and salicylic acid dusting powder,

clotrimazole dusting powder, starch and talk dusting powder

• Surgical Dusting Powders

o These are sterile powders used in body cavities for treatment of major

wounds such as burn wounds and umbilical cords in infants.

• Insufflations

o They are medicated finely divided powders for application into body

cavities (ears, nose, throat, vagina) by means of a device known as

“insufflators” or powder blower

o Produce local effect e.g. when applied into ears or systemic effect

e.g. when inhaled into the lungs and absorbed

o They are packaged in

o Insufflators (blowers) –for non potent drugs as it is difficult to

obtain uniform doses

o Pressurized aerosols –for potent drugs where the dose is adjusted

applied through a metered valve. Pressurized aerosols are also used

for administration of micronized powders

• Snuffs

o Snuffs are finely divided solid dosage forms of medicament that are

inhaled into the nostrils for antiseptic, bronchodilator, decongestion

actions

• Douche Powders

o These are powders that are completely soluble

o They are dissolved in water before they are used as antiseptics or

cleansing agents for body cavities e.g. vaginal use

• Triturates

o Powder triturates are dilutions of potent medications prepared by

mixing them well with a suitable diluent in a definite proportion by

weight .E.g. atropine sulfate in a lactose diluent

• Dentifrices

o These are dental cleansing powders

o They are powder prepared for use with the help of a tooth brush for

cleansing surfaces of the tooth

o They are available in forms of fine powders and pastes

o The powders contain

o a suitable detergent or soap

o mild abrasive substance e.g. calcium sulphate, magnesium carbonate,

sodium carbonate in fine powder;

o binder

o opacifiers

o humectants

o colouring agent

o sweetening agent e.g. saccharin sodium

o suitable flavour e.g. peppermint, clove oil

• Divided powders

o Divided powders are similar formulations to bulk powders but doses are

individually weighed and separately wrapped (packaged)

o Divided powders are dispensed in the form of individual doses and

generally are dispensed in papers, properly folded

o Traditionally in papers (unsatisfactory for most products, especially

if the ingredients are hygroscopic, volatile or deliquescent)

o Modern packaging materials of foil and plastic laminates have replaced

paper wrapping

o They also may be dispensed in metal foil, small heat-sealed plastic

bags or other containers

• Preparation of divided powders

o After weighing, comminuting and mixing the ingredients, the powders

must be divided accurately into the prescribed number of doses

o In order to achieve accuracy consistent with the other steps in the

preparation, each dose should be weighed individually and transferred

to a powder paper

o Following completion of this step, the powder papers are folded

• Divided powders include

o Packets

o Cachets

o Powders for injection (may be bulk or divided powder)

o Oral (Effervescent) powders or granules (may be bulk or divided)

▪ Packed in separate packages
▪ They are intended to be suspended or dissolved in water or mixed

with soft food

▪ The liquid formed or the food mix is consumed just after the

reaction (effervescence)

▪ Examples include antacids and laxative powders

STEP 6: Advantages and Disadvantages of Powders (20 minutes)

|Activity: Small Group Discussion (10 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What are advantages and disadvantages of powders? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• Advantages of Powders

o More stable than liquid dosage forms

o Rapid dissolution and absorption

o Offer rapid onset of action

o Easy to carry

o Flexibility of compounding/manufacturing

o Convenient for children and elderly

o Available for internal and external use

• Disadvantages of Powders

o Difficult to measure doses (leading to inaccurate dosing)

o Not suitable for bitter and nauseating drugs

o Not suitable for corrosive oral drugs

o Difficult to mask unpleasant organoleptic properties (taste, odour)

o Time consuming in dispensing

o Not suitable for hygroscopic drugs

o Not suitable for deliquescent drugs

o Volatile drugs difficult to dispense

STEP 7: Key Points (5 minutes)

• A pharmaceutical powder is a mixture of finely divided drug and /or

chemicals in dry form

• Powders are used as dosage forms or as starting materials for production

of other dosage forms

• Powders may classified into simple powders, compound powders, bulk

powders, divided powders, powders for external use or powders for

internal use

• Powder mix may be free flowing, cohesive or ordered mixtures
• Bulk powders involves packaging of non potent powders in bulk
• Bulk powders for external use include dusting powders, dentifrices,

insufflations, snuffs, douche powders and triturates

• Bulk powders for internal use include oral powders
• Divided powders are powders packaged in individual correctly weighed

doses. Potent drug powders are packed as divided powders.

• Divided powders include packets, cachets, powder for injection and oral

powders

STEP 8: Evaluation (5 minutes)

• What are the advantages of powders over other dosage forms?
• What is an insufflator?
• What is levigation?
• Explain the process of pulverization by intervention

References

Aulton M.E & Kevin M.G, Eds: (2013) Pharmaceutics: The design and

manufacture of medicines, (4th ed.) Churchill Livingstone

Gennaro, R. A, et.al (eds)( 1995) Remington: The Science and Practice of

Pharmacy, Volume I & II, (19th ed.) Mack Publishing Company, Easton,

Pennsylvania 18042

Liebsch, B et al. (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam

University Press.

Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice

of Pharmaceutics 12th Edition: The Pharmaceutical Press, London

Polderman, J (1990) Introduction to Pharmaceutical Production: Novib, The

Hague

Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, (8th

ed.). Baillie're Tindall

Schmidt, O.(2000) Pharmaceutical Quality systems, Interpharm Press,

Colorado.

Shayne C et al. (2008), Pharmaceutical Manufacturing Handbook: Production

and processes, John Wiley & Sons

Watson, D. G., (1999) Pharmaceutical Analysis: A Textbook for Pharmacy

Students and Pharmaceutical Chemists: Churchill Livingstone, Edinburgh

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