2. DEFINITION
ā¢ A Pharmaceutical powder is a mixture of ļ¬nely divided
drugs or chemicals in a dry form meant for internal or
external use.
ā¢ Powder as a dosage form permits drugs to be reduced to a
very ļ¬ne state of division, which often enhances their
therapeutic activity or eļ¬cacy by an increase of dissolution
rate and/or absorption.
ā¢ A good powder formulation has a uniform particle size
distribution. If the particle size distribution is not uniform, the
powder can segregate as per to particle size which may
result in inaccurate dosing or inconsistent performance.
3. Advantages of Powders
ā¢ Good chemical stability compared with ļ¬uids
ā¢ Useful for bulky drugs with large dose, e.g. indigestion powder.
ā¢ Easy to swallow even in large bulk, especially if mixed with
drink food (useful for stomach- tube feeding)
ā¢ The smaller particle size of powders causes more rapid
dissolution in body ļ¬uids, increases drug bioavailability, and
decreases gastric irritation compared with tablets
4. Disadvantages of Powders
ā¢ It is undesirable to take bitter or unpleasant tasting
drugs by oral administration.
ā¢ It is diļ¬cult to protect powders containing hygroscopic,
deliquescent (tending to melt or dissolve in humid
environment), or aromatic materials from decomposition.
ā¢ Chances of error in measurement of dose of powder.
ā¢ The particle size of a drug inļ¬uences the rate of
solubility in water.
5. Reduction of Particle Size
The manually operated procedures are trituration,
pulverization and levigation.
1- Trituration: It is used to comminute (reduce particle
size) & to mix powders.
ā¢ A porcelin preferred than glass morter.
ā¢ A glass morter is preferrable for chemicals that stain a
porcelin. When granular or crystalline materials are to
be incorporated in to powdered product ,these
materials are comminuted individually and then
blended together in the morter.
6. 2-Pulverization
ā¢ Substance are reduced & subdivided with an additional material
( i.e solvent) that can be removed easily after pulverization is
complete. It is used for hard crystalline powders that do not crush
or triturate easily, or gummy-type substances.
ā¢ * This technique is applied to
ā¢ Substances which are gummy and tend to reagglomerate or which
resist grinding. As camphor which is gummy, so addition of alcohol
or other volatile solvent can be reduced readily to a ļ¬ne powder.
ā¢ Similarly, iodine crystals may be comminuted with the
aid of ether.
ā¢ In both instances the solvent is permitted to evaporate
and the powdered material is recovered
7. 3- Levigation
Levigation is the process of grinding an insoluble substance to a
ļ¬ne powder, while wet.
In this process
A- paste is ļ¬rst formed by the addition of a suitable non solvent
to the solid material.
B-Particle-size reduction then accomplished by rubbing the paste
in a mortar with a pestle or on an ointmentā slab using a spatula.
8. TYPES OF POWDERS
1.Powders for internal use
(a) Divided powders
(i) Simple powders
(ii) Compound powders
(iii) Powders enclosed in cachet
(iv) Tablet triturates
(b) Bulk powders
(i) Antacid
(ii) Laxative
ā¢
2. Powders for external use
(a) Dusting powders
(i) Medicated dusting powders
(ii) Surgical dusting powders
(b) insufflations
(c) Douche powder
(d) Dentifrices
3. Special powders
(a) Eutectic mixtures
(b) Effervescent powders
9. 1.Powders for Internal use/Oral powders
ā¢ According to Indian Pharmacopoeia 2007, oral
powders are ļ¬nely divided powders that contain one or
more medicaments with or without auxiliary substances
including, where speciļ¬ed, ļ¬avouring and coloring
agents. However, addition of saccharin or its salts it not
permitted in the preparations meant for pediatric use.
ā¢ They are intended to be takeā internally with or without
the aid of water or any other suitable liquid.
ā¢ (a) Divided powders:
ā¢ Divided powders (or charta) are single doses of
powdered drugs individually wrapped in cellophane,
metallic foil, or paper.
10. ā¢ The divided powder is a more accurate dosage form than bulk powder
because the patient is not involved in measurement of the dose.
ā¢ Cellophane and foil-enclosed powders are better protected from the external
environment until the time of administration than paper-enclosed powders.
ā¢ Divided powders are commercially available in foil, cellophane or paper packs.
(i) Simple powder:
ā¢ it consists of only one active ingredient. If powder is in crystalline form, then it
is reduced to ļ¬ne.
ā¢ Example;-
ā¢ Aspirin Powder, Calcium Gluconate Powder etc.
ā¢ Aspirin powder -300 mg
ā¢ Procedure: Triturate aspirin so as to get ļ¬ne powder.
ā¢ Weigh the calculated amount of aspirin powder. Wrap each dose in individual
powder paper and pack it.
11. (ii) Compound powder:
ā¢ It consists of mixture of more than one active ingredient and other
constituents.
ā¢ Example:
ā¢ 1. Aspirin, Paracetamol and Caļ¬eine Powder
ā¢ Aspirin-300 mg
ā¢ Paracetamol-150 mg
ā¢ Caļ¬eine-50 mg
ā¢ Procedure:
ā¢ Triturate all the ingredients separately so as to get ļ¬ne powder.
ā¢ Weigh the calculated amount of aspirin powder; paracetamol powder and
caļ¬eine powder and mix them in ascending order of their weight.
ā¢ Wrap each dose in individual powder paper.
12. (iii) Powders enclosed in cachet:
ā¢ Cachets consist of a dry powder enclosed in a shell, usually prepared
from a mixture of rice ļ¬our and water by molding into a suitable shape
and drying.
ā¢ They are quite useful for administering the drugs with nauseating and
unpleasant taste and a large dose can be enclosed in a cachet than in
a tablet or capsule.
ā¢ A cachet oļ¬ers little protection against light -and moisture.
ā¢ Now-a-days cachets are replaced by capsule. There are two types of
catches:
Wet cachets:
ā¢ Lower half of the cachet is ļ¬lled with powdered drug, then the ļ¬ange of
the empty upper half of the cachet is moistened with water and
pressed over the lower half.
ā¢ The cachet is dried for 15 minutes.
13. Dry cachets:
ā¢ Drug powder is ļ¬lled in the lower half and the upper half
is pressed over it just like a capsule.
ā¢ They are used for administering the drug with
unpleasant taste and a large dose.
ā¢ Before administration, a cachet should be immersed in
water for few seconds and then placed on the tongue
and swallowed with water.
ā¢ Example:-
ā¢ Sodium Amino salicylate Cachets,
ā¢ Sodium Amino salicylate with lsoniazid Cachets.
14. (iv) Tablet triturates:
ā¢ Tablet triturates are powders molded into tablets.
ā¢ Tablet triturates are generally prepared by mixing the
active drug with lactose, dextrose, sucrose, mannitol,
or some other appropriate diluents that can serve as
the base.
ā¢ This base must be readily water soluble and should
not degrade during the tablet's preparation.
ā¢ Lactose is the preferred base but mannitol adds a
pleasant, cooling sensation and additional sweetness
in the mouth
15. ā¢ Tablet triturates are used for oral administration or
sublingual use
ā¢ (For example, nitroglycerin tablets)
ā¢ They may also be used in compounding procedures by
pharmacists in the preparation of other solid or liquid
dosage forms.
ā¢ They can be inserted into capsules, and this eliminates
the problems of measuring the accurate amount of
potent drugs in the powder form.
ā¢ Example:
ā¢ Propranolol Scopolamine Tablet Triturate; Propranolol
hydrochloride 40 mg, Scopolamine hydrobromide 0.5 mg
16. (b) Bulk powder
ā¢ Bulk powders are non-potent and can be closed with
acceptable accuracy and safety using measuring
devices such as the teaspoon, cup, or insuļ¬ators.
ā¢ The mixed ingredients are packed into a suitable bulk
container, such as a wide- mouthed glass jar. Because
of the disadvantages of this type of preparation the
constituents are usually relatively non-toxic
medicaments with a large dose.
ā¢ This practically limits the use of orally administered
bulk Powders to antacids, dietary supplements,
laxatives, and a few analgesics.
17. (I) Antacid
ā¢ Example:
ā¢ Magnesium Trisilicate Oral Powder BP
ā¢ Magnesium trisilicate-250 mg
ā¢ Chalk-250 mg
ā¢ Heavy magnesium carbonate-250 mg
ā¢ Sodium bicarbonate-250 mg
ā¢ All powders are sieved using 250 um sieve and mixed well by
triturating them in mortar. The ļ¬nal product is packed in amber
colored glass jar or plastic container with screw cap.
ā¢ Use:- For relief of the symptoms of indigestion, heartburn and
dyspepsia.
18. (ii) Laxative Example:
ā¢ Polyethylene Glycol 3350 NF Powder for Oral Solution
ā¢ Polyethylene glycol 3350-13.125 9
ā¢ Sodium chloride-350.7 mg
ā¢ Sodium hydrogen carbonate-178.5 mg
ā¢ Potassium chloride-46.6 mg
ā¢ Polyethylene glycol 3350 NF powder for oral solution is
an osmotic agent which causes water to be retained with
the stool and used for the treatment of constipation. it is
supplied in powdered form, for oral administration after
dissolution in water, juice, soda, coļ¬ee, or tea.
19. 2. Powders for external use
(a) Dusting powders
ā¢ Dusting Powders are externally used bulk powders. They are free
ļ¬owing very ļ¬ne powders containing antiseptics, antipruritics,
astringents, antiperspirants, absorbents, lubricants etc.
(i) Medicated dusting powders:
ā¢ Medicated dusting powders are sterile ones and meant for
application on superļ¬cial skin.
ā¢ Body dusting powders have a wide appeal because of smooth
feel and cooling eļ¬ect, which they impart while they temporarily
absorb moisture.
ā¢ The cooling eļ¬ect is due to extra heat loss due to large surface
area of talc particles.
20. ā¢ Talc-51 g
ā¢ Kaolin-15g
ā¢ Precipitated chalk-21g
ā¢ Zinc stearate-3g
ā¢ Boric acid-5g
ā¢ Salicylic acid-5g
ā¢ Perfume Quantity suļ¬cient
ā¢ Talc in a major ingredient in medicated dusting powder
formulation, which should have good slip
characteristics, covering power and body adhesion.
21. ā¢ In order to improve adhesion properties, metallic
stearates such as zinc stearate or magnesium stearate
and kaolin are incorporated.
ā¢ To improve absorbency, magnesium carbonate, starch,
kaolin and precipitated chalk are used in combination.
ā¢ Zinc oxide and titanium dioxide, at low levels along with
earth colors can be incorporated and should be
suļ¬ciently powerful to cover the base odour.
ā¢ Other ingredients sometimes included are boric acid to
act as skin buļ¬ering agent and fused silica to give
powder a lower density; salicylic acid for antibacterial
action. Aluminum chloride is also incorporated as an
antiperspirant
22. (ii) Surgical dusting powders:
ā¢ Surgical dusting powders are intended to be used into
deep layer of skin and also on major wounds as a result
on burns and umbilical cords of infants. Surgical dusting
powders must be free from pathogenic microorganism
and hence it must be sterilized before their use.
ā¢ The dusting powders are mainly used for their antiseptic,
astringent, absorbent, antiperspirant, and antipruritic
action.
ā¢ It mainly contains antimicrobial agents like chlorhexidine
and hexachlorophene.
ā¢ They are generally prepared by mixing two or more
ingredients one of which must be starch, talc or kaolin as
one of the ingredients of the formulation.
23. ā¢ Talc is more commonly used because of its chemical
inertness.
ā¢ However, since such ingredients are readily
contaminated with pathogenic bacteria, these must be
sterilized by dry heat method before use.
ā¢ Dusting powders are dispensed in Sifter-top container
or aerosol containers.
ā¢ It may also be applied with powder puļ¬ or sterilized
gauze pad.
24. Example:
ā¢ Neosporin Dusting Powder
ā¢ Bacitracin (5000 IU)
ā¢ Neomycin (3400 IU)
ā¢ Polymyxin B (400 IU)
ā¢ Bacitracin is an antibiotics that acts by inhibiting the
growth of bacteria in the wounds. It is used alone or in
combination with neomycin and polymyxin to treat and
prevent superļ¬cial and minor skin infections due to
wounds, cuts burns.
25. ā¢ Neomycin belongs to the class of medications called it
antibiotics. it prevents the bacterial growth by
stopping the production of essential protein in the
bacterial cells, thereby relieving the associated
symptoms.
ā¢ Polymyxin B belongs to a group of medications called
as polypeptide antibiotic. It works by killing the
bacteria that causes the infection.
26. (b) lnsuļ¬ations
ā¢ lnsuļ¬ations are medicated dusting powders meant for
introduction into the body cavities such as nose, throat, ears, etc.
with the help of an apparatus known as insuļ¬ators (powder
blower).
ā¢ lt sprays the powder into a stream of ļ¬nely divided particles all over
the site of application.
ā¢ The insuļ¬ations are used to produce a local eļ¬ect, as in the
treatment of ear, nose and throat infection with antibiotics or to
produce a systemic eļ¬ect from a drug that is destroyed in the
gastrointestinal tract.
ā¢ As like aerosols, uniform dose may not be obtained by insuļ¬ations.
Examples:
ā¢ Cromolyn Sodium Powder,
ā¢ Compound Clioquin Powder USP
27. (c) Douche powder
ā¢ Douche powders are intended to be used as antiseptics or cleansing agents
for a body cavity; most commonly for vaginal use, although they may be
formulated for nasal, otic or ophthalmic use also.
ā¢ As douche powder formulation often include aromatic oils. it becomes
necessary to pass them through a sieve 40 or 60 to eliminate agglomeration
and to ensure complete mixing.
ā¢ They can be dispensed either in wide mouth glass bottles or in powder
boxes but the former are preferred because of protection aļ¬orded against
air and moisture.
ā¢ Example: Douche powder
ā¢ Zinc sulphate Magnesium sulphate
ā¢ Boric acid
ā¢ Lemon oil
ā¢ Puriļ¬ed water
28. (d) Dentifrices
ā¢ Dentifrices are preparations meant to clean the teeth
and other parts of oral cavity (gums) using a ļ¬nger or a
toothbrush.
ā¢ They are available as tooth powder, toothpastes, gels,
dental creams and even as dental foams.
ā¢ They are meant to enhance the personal appearance
of the teeth (daily removal of pellicles) by maintaining
cleaner teeth.
29. ā¢ Reduction of bad odour (removal of putrifying food
particles from spaces between teeth) and also make
the gum healthy.
ā¢ They contain a suitable detergent or soap, some
abrasive substance and a suitable ļ¬avour.
ā¢ The abrasive agents such as calcium sulphate,
magnesium carbonate, sodium carbonate and sodium
chloride are used in ļ¬ne powder form.
ā¢ The main components of tooth powders are solid
particles of very ļ¬ne size and the end product is also a
very dry powder.
30. ā¢ Since the main components like abrasives, surface active
agent are solid powders, it is required that they all are in very
ļ¬ne particle size, comminuted, if desired, passed through a
sieve and mixed in a mortar in the lab scale and in blenders on
an industrial scale.
ā¢ Hard soap (in ļ¬ne powder) -50g
ā¢ Precipitated calcium carbonate -935g
ā¢ Saccharine sodium -2g
ā¢ Peppermint oil -4ml
ā¢ Cinnamon oil -2ml
ā¢ Methyl salicylate- 8ml
ā¢ To make-about -1000g
31. 3. Special powders
(a) Eutectic mixtures:
ā¢ Eutectic mixtures are deļ¬ned as mixtures of low melting point
ingredients which on mixing together turn to liquid form due to
depression in melting point of the mixture below room temperature.
ā¢ They are mixtures of substances, that liquefy when mixed, rubbed
or triturated together.
ā¢ Examples of the substances which tend to liquefy on mixing are
camphor, thymol, menthol, salol.
ā¢ Any two of these drugs turn to liquid when mixed.
ā¢ This problem during formulation of powders of such material can
be solved by using inert adsorbent such as starch, talc, lactose to
prevent dampness of the powder and dispensing the components
of the eutectic mixture separately.
32. (b) Eļ¬ervescent powders:
ā¢ Eļ¬ervescent powders contain materials which react in
presence of water evolving carbon dioxide.
ā¢ This class of preparations can be supplied either by
compounding the ingredients as granules or
dispensed in the form of salts.
ā¢ For evolution of the gas two constituents are essential,
a soluble carbonate such as sodium bicarbonate and
an organic acid such as citric or tartaric acid.
ā¢ The preparation can be supplied either as a bulk
powder or distributed in individual powders.
33. PREPARATION OF POWDERS
ā¢ Reduction of size
ā¢ Mixing homogeneously
ā¢ Geometric dilution
ā¢ Packaging
34. Particle size reduction:
ā¢ For preparation of powder, each ingredient should be
needed in ļ¬nely ground form; hence manufacturer
must use a number of procedures and equipment to
reduce the particle size of powder ingredients, this
process is called as comminution.
ā¢ The most common method used for particle size
reduction in powder formulation is trituration which
involves placing the solid in a mortar and continually
grinding the chemical between the mortar and the
pestle using a ļ¬rm, downward pressure.
ā¢ A small mesh sieve can be used to determine the
prevalent particle size of a powder after it has been
triturated.
35. Preparing a homogenous mixture:
ā¢ Particle size reduction is followed by homogeneous mixing of
all powder ingredients. Many times processes similar to those
used for particle size reduction are used for obtaining
homogenous mixture.
ā¢ It is especially eļ¬ective for mixing small quantities of potent
drugs with larger amounts of diluents. Hazardous substances
can be eļ¬ectively mixed by a process called tumbling.
ā¢ The powders are sealed in zipper-sealed bags or clear bottles
with a
ā¢ lid and tumbled until they are well mixed.
ā¢ The addition of a coloring agent can assist in determining
homogeneity in the mixture. If powders being combined are
unequal in quantity, then geometric dilution method is used
36. Geometric dilution:
ā¢ Geometric dilution is the process by which a homogenous mixture or
even distribution of two or more substances is achieved. This method is
used when potent substances must be mixed with a large amount of
diluent.
ā¢ The potent drug and an approximately equal volume of diluent are placed
in a mortar and thoroughly mixed by trituration.
ā¢ A second portion of diluent, equal in volume to the powder mixture in the
mortar is added, and trituration is repeated.
ā¢ The process is continued; equal volumes of diluent are added to the
powder mixture in the mortar until all of the diluent is incorporated.
ā¢ For example, if dose of potent drug is 120 mg, while mixing entire
quantity (120 mg) of potent drug is taken and to it 120 mg of the diluents
are added and mix thoroughly.
ā¢ The resulting 240 mg mixture of potent drug and diluents is again mixed
with further 240 mg of diluents and the process is repeated until all the
diluents are incorporated
37. Packaging of powders:
ā¢ Bulk powders for external use (sometimes called dusting powders) are
often dispensed in a shaker-top container to facilitate topical application.
ā¢ They may also be dispensed in a wide-mouth jar or a plastic container
with a ļ¬ip-top lid.
ā¢ The jar or plastic container can be closed tightly to provide increased
stability and protection from light and moisture, especially for compounds
that contain volatile ingredients. Package should contain label as "For
external use onlyā.
ā¢ Bulk powders intended for internal use should be dispensed in an amber
colored, wide-mouth powder jar with a tight-ļ¬tting lid.
ā¢ They should be accompanied by an appropriately sized dosing spoon or
cup and adequate directions for removing and administering a correct
dose.
ā¢ Bulk powders for internal use should be labeled with the strength of the
active ingredient per dose (e.g., Potassium chloride 600 mg per
tablespoonful).
39. Introduction
ā¢ Weighing is a well-established approach to measuring
the weight of an object and involves using a weighing
device (e.g., a set of scales) to quantify amounts of
ingredients.
41. Analytical balances
ā¢ Very accurate balances, called analytical balances, are
used in scientiļ¬c ļ¬elds such as chemistry.
ā¢ An analytical balance is a class of balance designed to
measure small mass in the sub-milligram range.
42. Analytical Balance (principal of operation):
(i) sample on balance pushes the pan down with a
force equal to m x g
ā¢ M is mass of object
ā¢ g is acceleration of gravity
(ii) balance pan with equal and opposing mass
ā¢ Mechanical ā standard masses
ā¢ Electronic ā opposing electromagnetic force
(iii) tare āmass of empty vessel (pan)
m1l1 = m2l2
m1 m2
l1 l2
m m
43. Single-pan balance
ā¢ balance beam suspended on a sharp knife edge
ā¢ Sample pan is balanced by counterweights on right
ā¢ Knob adjusted to remove weights from a bar above the pan
ā¢ Pan is moved back to its original position and the removed
ā¢ weights equals the mass of the sample.
44. Double-pan balance
ā¢ balance beam suspended on a sharp knife edge
ā¢ Standard weights are added to the second pan to
balance sample weight
ā¢ Weight of sample is equal to the total weight of
standards
45. Electronic balance
ā¢ Uses electromagnetic force to return the pan to original position
ā¢ Electric current required to generate the force is proportional to
sample mass.
ā¢ Very accurate balances, called analytical balances, are used in
scientiļ¬c ļ¬elds such as chemistry.
ā¢ An analytical balance is a class of balance designed to measure
small mass in the sub-milligram range.
46. ā¢ Electronic balances are found throughout most
laboratories.
ā¢ They are mostly used to weigh substances and
samples between 0.01 to 500 milligrams.
ā¢ These unitsā measuring pans are usually encased in a
glass box so as to prevent any dust particles settling
in the pan.
ā¢ An analytical balance measures masses to within
0.0001 g.
ā¢ Use these balances when you need this high degree
of precision.
47. Weight Measurements
Methods of Weighing:
(i) Basic operational rules
ā¢ Chemicals should never be placed directly on the weighing pan
- corrode and damage the pan may affect accuracy
- not able to recover all of the sample
ā¢ Balance should be in arrested position when load/unload pan
(ii) Weight by difference:
ā¢ Useful for samples that change weight upon exposure to the
atmosphere
- hygroscopic samples (readily absorb water from the
air)
Weight of sample = ( weight of sample + weight of container) ā weight of
container
(iii) Taring:
ā¢ Done on many modern electronic balances
ā¢ Container is set on balance before sample is added
ā¢ Containerās weight is set automatically to read ā0ā
48. Weight Measurements
Errors in Weighing: Sources
(i) Any factor that will change the apparent mass of the
sample
ā¢ Dirty or moist sample container
- also may contaminate sample
ā¢ Sample not at room temperature
- avoid convection air currents (push/lift
pan)
ā¢ Adsorption of water, etc. from air by sample
ā¢ Vibrations or wind currents around balance
ā¢ Non-level balance
49. Website: www.probecell.com Email: probecellinfo@gmail.com
Ph: 7415211131
Ofļ¬ce: Smriti Nagar, Bhilai, Chhattisgarh - 490020
https://youtube.com/c/ParagJainthunderpassionate https://www.facebook.com/thesisresearchwriting
Research article Review article Thesis Synopsis PhD Title Research guidance