1. Compoundin g Dr. Muslim Suardi, MSi., Apt. Faculty of Pharmacy University of Andalas Powders (Pulvis et Pulveres)

2. Pharmaceutical Powder Pharmaceutical Powder “a mixture of finely divided drugs or chemicals in a dry form meant for internal or external use”

3. Powder The word "powder" refers to a chemical or mixture that is solid in physical state. The word "powder" refers to a chemical or mixture that is solid in physical state. In compounding, "powder" refers to a dosage formulation that is solid in physical state. But the formulation may be composed of only the active drug or may be a mixture of the active drug & other ingredients. In compounding, "powder" refers to a dosage formulation that is solid in physical state. But the formulation may be composed of only the active drug or may be a mixture of the active drug & other ingredients.

4. Powder Frequently prescribed by physician Frequently prescribed by physician Divided powders Divided powders Bulk powders Bulk powders Dusting powder Dusting powder Capsules Capsules Granules Granules

5. Types of Pharmaceutical Powders Oral powders Oral powders Topical powders, Dusting powders Topical powders, Dusting powders Powders for inhalation Powders for inhalation Insufflations powders as a starting material Insufflations powders as a starting material Caps, Tab Dispersions, Injections Caps, Tab Dispersions, Injections Suspensions reconstituted Suspensions reconstituted

6. Advantages Wide choice of ingredients & varying doses can be prescribed to fulfill the individual patient needed Wide choice of ingredients & varying doses can be prescribed to fulfill the individual patient needed It is convenient for the physician to prescribe a specific amount of powder It is convenient for the physician to prescribe a specific amount of powder Each dose can contain a different amount of active drug Each dose can contain a different amount of active drug Easy to carry Easy to carry

7. Advantages Fewer incompatibility than in liquids Fewer incompatibility than in liquids Since small particle size & no desintegration step look like tablets, dispersion of ingredients will be rapid Since small particle size & no desintegration step look like tablets, dispersion of ingredients will be rapid A greater & more rapid dissolution in the stomach A greater & more rapid dissolution in the stomach On set of action is faster as compared to tablet, capsules, because it is easily in dissolved in body fluids On set of action is faster as compared to tablet, capsules, because it is easily in dissolved in body fluids

8. Advantages

9. Advantages When it is not possible to dispense a drug as a solution or a suspension, because of its insolubility or because it is susceptible to microbial contamination if it is wetted, then it is a good idea to dispense it as a powder. When it is not possible to dispense a drug as a solution or a suspension, because of its insolubility or because it is susceptible to microbial contamination if it is wetted, then it is a good idea to dispense it as a powder. Easy administration to the patient orally by dissolving in suitable liquids Easy administration to the patient orally by dissolving in suitable liquids

10. Advantages When the patient has to mix the ingredients before administration, dispensing in separate divided powders is a convenient way. When the patient has to mix the ingredients before administration, dispensing in separate divided powders is a convenient way. Bulky doses or large volume can be more easily taken by the patient, it mean a powder is a good way of administering it. Bulky doses or large volume can be more easily taken by the patient, it mean a powder is a good way of administering it.

11. Advantages It can be administered easily to infants, young children, geriatry or other patients who cannot swallow tablets or capsules. In such situations powders are a good option. It can be administered easily to infants, young children, geriatry or other patients who cannot swallow tablets or capsules. In such situations powders are a good option. Flexibility of compounding. Flexibility of compounding.

12. Advantages Good chemical stability related with moisture, oxidized, & interaction. Good chemical stability related with moisture, oxidized, & interaction. Drugs tend to most stable as a solid Drugs tend to most stable as a solid It is more stable than liquid dosage form. It is more stable than liquid dosage form.

13. Advantages It is used both internally & externally It is used both internally & externally Can be applied to many body cavities: ears, nose, tooth socket, throat Can be applied to many body cavities: ears, nose, tooth socket, throat Can be made into many different dosage formulations: capsules, tablets, powders for reconstitution, dusting powders, bulk powders, powders for inhalation, etc. Can be made into many different dosage formulations: capsules, tablets, powders for reconstitution, dusting powders, bulk powders, powders for inhalation, etc.

14. DISADVANTAGES Time-consuming preparation Time-consuming preparation Quantity <100 mg cannot be weighed conveniently Quantity <100 mg cannot be weighed conveniently Inaccuracy of dose (size of measuring spoon, density of powder, humidity, degree of settling, fluffiness). Inaccuracy of dose (size of measuring spoon, density of powder, humidity, degree of settling, fluffiness). Unsuitability for many unpleasant tasting, hygroscopic & deliquescent drugs. Unsuitability for many unpleasant tasting, hygroscopic & deliquescent drugs.

15. DISADVANTAGES Bitter taste, nausea & unpleasant taste drugs can’t be administered in powder form. Deliquescent & hygroscopic drugs can’t be dispensed in powder form they are packed in double wrapping. Drugs which get affected by atmospheric condition aren’t suitable for dispense. Bitter taste, nausea & unpleasant taste drugs can’t be administered in powder form. Deliquescent & hygroscopic drugs can’t be dispensed in powder form they are packed in double wrapping. Drugs which get affected by atmospheric condition aren’t suitable for dispense.

16. List of Mesh Sizes Mesh Size NumberMesh Opening Size MillimetersMicrons 29.529520 102.002000 200.84840 400.42420 600.250250 800.177177 1000.149149 2000.07474

17. Usage Based Classification Divided Powders (Pulveres) Divided Powders (Pulveres) Bulk Powders (Pulvis for internal used) Bulk Powders (Pulvis for internal used) Dusting Powders (Pulvis adspersorius) Dusting Powders (Pulvis adspersorius) Douche Powders Douche Powders Insufflations Insufflations Powder Sprays Powder Sprays Dental Powder (Pulvis dentrificius) Dental Powder (Pulvis dentrificius)

18. Size Based Classification Description TermMesh Opening Size (microns)Mesh Size Number Very Coarse> 10002 - 10 Coarse355 -100020 - 40 Moderately Coarse180 - 35540 - 80 Fine125 - 18080 - 120 Very Fine90 - 125120 - 200

19. Reducing Particle Size Objectives: Uniform & finely divided mixture. Methods: Trituration Trituration Spatulation Spatulation Sifting Sifting Tumbling Tumbling

20. Trituration Mortar methods, (mortar & pestles, or mortir & stamfer) Mortar methods, (mortar & pestles, or mortir & stamfer) Most frequently Most frequently Used for both pulverization & mixing Used for both pulverization & mixing Glass mortars are preferred for dyes & highly colored materials Glass mortars are preferred for dyes & highly colored materials

21. Spatulation Used to mix small quantities of powders & combination of powders having the same densities. Used to mix small quantities of powders & combination of powders having the same densities. A powder spatula is used as the mixing instrument, & the powders are stirred on a pill tile or piece of clean paper. A powder spatula is used as the mixing instrument, & the powders are stirred on a pill tile or piece of clean paper.

22. Sifting Sifting is an excellent way to mix powders that resist mixing by trituration. Sifting is an excellent way to mix powders that resist mixing by trituration. Exceedingly light powders such as MgO & charcoal can be rapidly & completely mixed by shaking them through a sieve. Exceedingly light powders such as MgO & charcoal can be rapidly & completely mixed by shaking them through a sieve. Any large particles which do not pass through the sieve should be powdered by trituration & then re-sieved. Any large particles which do not pass through the sieve should be powdered by trituration & then re-sieved.

23. Tumbling Mixing powders together by shaking or rotating them in a closed container. Mixing powders together by shaking or rotating them in a closed container. This is a simple mixing process & does not effect any reduction in particle size. This is a simple mixing process & does not effect any reduction in particle size.

24. Mixing Crystalline salts, even if already powdered, are mixed best by trituration. Crystalline salts, even if already powdered, are mixed best by trituration. Chlorobutanol & phenyl salicylate electrify & stick or fly when rubbed Chlorobutanol & phenyl salicylate electrify & stick or fly when rubbed Salts with contain much water of crystallization, such as alum, sodium phosphate, etc., may need to be dried before mixing, to prevent reactions. Salts with contain much water of crystallization, such as alum, sodium phosphate, etc., may need to be dried before mixing, to prevent reactions.

25. Powerful Remedies Mixing An equal bulk of diluent with the potent drug is first placed in the mortar & triturated until well mixed, then a double volume more of added & mixed before a further quantity is added. An equal bulk of diluent with the potent drug is first placed in the mortar & triturated until well mixed, then a double volume more of added & mixed before a further quantity is added.

26. Incompatible Salts Mixing Should be mixed lightly, as pressure may start a reaction. Should be mixed lightly, as pressure may start a reaction. Rolling on a sheet of paper is a convenient method for avoiding pressure. Rolling on a sheet of paper is a convenient method for avoiding pressure.

27. Eutectic Mixtures When phenols or phenolic compounds, aldehyde compounds & ketonic bodies are mixed, the mixture may have a melting point considerably below that of any of the individual ingredients When phenols or phenolic compounds, aldehyde compounds & ketonic bodies are mixed, the mixture may have a melting point considerably below that of any of the individual ingredients A suitable remedy for most eutetic mixtures is the addition of an inert powder to separate the offending powder. A suitable remedy for most eutetic mixtures is the addition of an inert powder to separate the offending powder.

28. Bulk Powders Nonpotent & can be dosed with acceptable accuracy & safety using measuring devices such as the teaspoon, cup, or insufflator Nonpotent & can be dosed with acceptable accuracy & safety using measuring devices such as the teaspoon, cup, or insufflator This practically limits the use of orally administered bulk powders to antacids, dietary supplements, laxatives, & a few analgesics. This practically limits the use of orally administered bulk powders to antacids, dietary supplements, laxatives, & a few analgesics. Many bulk powders are used topically. Many bulk powders are used topically.

29. Dispensed in Bulk Powder Powders which are applied externally as antiseptic or dusting powders Powders which are applied externally as antiseptic or dusting powders In relatively large doses such as a teaspoonful at a time In relatively large doses such as a teaspoonful at a time Some powders used to make solutions. Some powders used to make solutions.

30. Dosage Bulk Powder Usually measured out by the patient Usually measured out by the patient All other forms of powder the dosage is measured & package by the pharmacist. All other forms of powder the dosage is measured & package by the pharmacist.

31. Bulk Powder Dispense in either cardboard glass containers. Dispense in either cardboard glass containers. Topically powders: special shaker-top boxes are used Topically powders: special shaker-top boxes are used Drug to be taken u.i, glass wide-mouth bottles of appropriate size are the containers of choice. Drug to be taken u.i, glass wide-mouth bottles of appropriate size are the containers of choice.

32. Bulk Powder When volatile oils or aromatic substance are contained in the prescription, air-tight containers should be used. When volatile oils or aromatic substance are contained in the prescription, air-tight containers should be used. Appropriate auxiliary labels should be used on bulk powders for u.e. Appropriate auxiliary labels should be used on bulk powders for u.e.

33. Dusting Powders Dusting powders are fine medicinal (bulk) powders intended to be dusted on the skin by means of sifter-top containers. Dusting powders are fine medicinal (bulk) powders intended to be dusted on the skin by means of sifter-top containers. A single medicinal agent may be used as a dusting powder; however, a base is frequently used to apply a medicinal agent and to protect the skin from irritation and friction. A single medicinal agent may be used as a dusting powder; however, a base is frequently used to apply a medicinal agent and to protect the skin from irritation and friction.

34. Dusting Powders Bentonite, kaolin, kieselguhr, MgCO3, starch, & talc are used as inert bases for dusting powders. Bentonite, kaolin, kieselguhr, MgCO3, starch, & talc are used as inert bases for dusting powders. Powder bases absorb secretions & exert a drying effect, which relieves congestion & imparts a cooling sensation. Powder bases absorb secretions & exert a drying effect, which relieves congestion & imparts a cooling sensation.

35. Dusting Powders All extemporaneous dusting powders should be passed through a 100-200 mesh sieve to ensure that they are grit free and will not further mechanically irritate traumatized areas All extemporaneous dusting powders should be passed through a 100-200 mesh sieve to ensure that they are grit free and will not further mechanically irritate traumatized areas

36. Douche Powders Used to prepare solutions that cleanse the vagina. Used to prepare solutions that cleanse the vagina. Most of them are used for their hygienic effects, but a few contain antibiotics. Most of them are used for their hygienic effects, but a few contain antibiotics. Prescribed as a matter of convenience for the patient, since a powder is more portable than a bulky solution. Prescribed as a matter of convenience for the patient, since a powder is more portable than a bulky solution.

37. Douche Powders The formula is developed so that a teaspoonful or tablespoonful of powder dissolved in a specified volume of water provides the desired concentration. The formula is developed so that a teaspoonful or tablespoonful of powder dissolved in a specified volume of water provides the desired concentration. The pH usually ranges from 3.5 to 5 when the solution is prepared. The pH usually ranges from 3.5 to 5 when the solution is prepared. Feminine bulb syringes or fountain syringes are used for vaginal irrigation. Feminine bulb syringes or fountain syringes are used for vaginal irrigation.

38. Douche Powders Since many of the ingredients are volatile (e.g., menthol, thymol, & volatile oils), douche powders should be packaged in glass jars with a wide mouth. Since many of the ingredients are volatile (e.g., menthol, thymol, & volatile oils), douche powders should be packaged in glass jars with a wide mouth. Some commercial are available in metal foil packets, which contain the proper amount of powder for a single douche. Some commercial are available in metal foil packets, which contain the proper amount of powder for a single douche.

39. Insufflations Extremely fine powders to be introduced into body cavities. Extremely fine powders to be introduced into body cavities. To administer an insufflation, the powder is placed in the insufflator, and when the bulb is squeezed, the air current carries the fine particles through the nozzle to the region for which the medication is intended. To administer an insufflation, the powder is placed in the insufflator, and when the bulb is squeezed, the air current carries the fine particles through the nozzle to the region for which the medication is intended.

40. Insufflations All extemporaneously compounded insufflations must be passed through a 100 mesh sieve. All extemporaneously compounded insufflations must be passed through a 100 mesh sieve. Pressurized packages provide an elegant approach to the administration of insufflations. Pressurized packages provide an elegant approach to the administration of insufflations.

41. Powder Sprays In contrast to dusting powders, powders dispensed under pressure will deliver targeted and uniform application at the desired site. In contrast to dusting powders, powders dispensed under pressure will deliver targeted and uniform application at the desired site. Also, in an aerosol container medicated powders may be maintained in a sterile condition. Also, in an aerosol container medicated powders may be maintained in a sterile condition.

42. Powder Sprays The powder particles must be a definite size range to prevent clogging of the valve orifice and to provide uniformity of application. The powder particles must be a definite size range to prevent clogging of the valve orifice and to provide uniformity of application. In general, powders that are to be packaged as powder sprays must not contain particles greater than 50 microns if they are to be sprayed successfully. In general, powders that are to be packaged as powder sprays must not contain particles greater than 50 microns if they are to be sprayed successfully.

43. Divided Powders (Pulveres) Divided powders or charts are single doses of powdered medicinals individually wrapped in cellophane, metallic foil, or paper. Divided powders or charts are single doses of powdered medicinals individually wrapped in cellophane, metallic foil, or paper. The divided powder is a more accurate dosage form than bulk powder because the patient is not involved in measurement of the dose. The divided powder is a more accurate dosage form than bulk powder because the patient is not involved in measurement of the dose.

44. Divided Powders (Pulveres) Cellophane and foil-enclosed powders are better protected from the external environment until the time of administration than paper-enclosed powders. Cellophane and foil-enclosed powders are better protected from the external environment until the time of administration than paper-enclosed powders. Divided powders are commercially available in foil, cellophane or paper packs. Divided powders are commercially available in foil, cellophane or paper packs.

45. Granulations Particles ranging in size from about 4- 10 mesh. Particles ranging in size from about 4- 10 mesh. Generally made by first blending the powders together & then moistening the mixture to form a pasty mass. Generally made by first blending the powders together & then moistening the mixture to form a pasty mass. The mass is passed through a sieve & then dried in air or in an oven. The mass is passed through a sieve & then dried in air or in an oven.

46. Granulations They are prepared as a convenience for packaging, as a more stable product due to less surface exposure, & as a popular dosage form. Granulations are also used as intermediates in the preparation of capsules & tablets, since they flow more smoothly & predictably than do small powder particles. They are prepared as a convenience for packaging, as a more stable product due to less surface exposure, & as a popular dosage form. Granulations are also used as intermediates in the preparation of capsules & tablets, since they flow more smoothly & predictably than do small powder particles.

47. Granulations The most popular compounded granulation is the effervescent powder (sometimes called effervescent salts). The most popular compounded granulation is the effervescent powder (sometimes called effervescent salts). They are popular due to their taste & psychological impression. They are popular due to their taste & psychological impression. When added to water, the granulation effervesces ("fizzes") as CO 2 is liberated. When added to water, the granulation effervesces ("fizzes") as CO 2 is liberated.

48. Preparation of Effervescent Granulation It has been found that citric acid monohydrate & tartaric acid used in the certain ratio, produces a powder with good effervescent properties. It has been found that citric acid monohydrate & tartaric acid used in the certain ratio, produces a powder with good effervescent properties. Citric acid monohydrate is not used alone because it results in a sticky mixture that will not easily granulate. Citric acid monohydrate is not used alone because it results in a sticky mixture that will not easily granulate.

49. Effervescent Granulation Tartaric acid is not used alone because the granules are too friable & crumble Tartaric acid is not used alone because the granules are too friable & crumble The amount of NaHCO 3 to be used may be calculated from the reaction which occur when the granules come in contact with water. The amount of NaHCO 3 to be used may be calculated from the reaction which occur when the granules come in contact with water.