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level: GRANULES LEVEL 1

Questions and Answers List

level questions: GRANULES LEVEL 1

Question	Answer
Dosage form composed of dry aggregates or powder particles that may contain one or more APIs, with or without other ingredients Swallowed, dispersed in food, dissolved in water Compacted into tablets or filled in capsules Agglomerates of smaller particles of powders Irregularly shaped, spherical 4-12- mesh size range Less likely to cake or harden	Granules
Advantages of Granules	1 Usually made as a step to prepare tablets 2 Flows easily into the dies more evenly and more freely 3 Flow better than powders 4 It eliminates or control dust
Is the size enlargement process in which primary powders particles are made to adhere to form larger, multi particle entities called granules. It is the process of collecting particles together by creating bonds between them	Granulation
Granulation Two methods:	1 Dry Method (Slugging) 2 Wet Method (use of binding agent)
Reasons for granulation	1 To prevent segregation of the constituents of powder mix 2 To improve the flow properties of the powder mix 3 To improve the compaction characteristics of powder mix Pneumonic: SegFloCom
Moisten the powder mixture and then pass the resulting paste through a screen of mesh size to produce desired size of granules Granules are place on drying trays and aid dried or under heat Move periodically to prevent adhesion into large mass	Wet methods
Particles are places in a conical piece of equipment and vigorously dispersed and suspended while liquid excipient is sprayed on the particles and then dried	Fluid bed processing
Types of Granules	1 BIAXIN 2 OMNICEF 3 LACTINEX 4 ZANTAC Pneumonic: BOLZ
contact in water, rapidly release CO2 Granules or coarse to very coarse powders containing medicinal agent in a dry mixture usually composed of NaHCO3, Citric acid, tartaric acid Carbonated solution masks the undesirable taste	Effervescent granulated salts
Effervescent granulated salts 1 granules lose their firmness and crumble 2 sticky mixture difficult to granulate	1 Tartaric acid 2 Citric acid
The one molecule of water present in each molecule of citric acid acts as a binding agent for the powder mixture. Before mixing the powder, the citric acid crystals are powdered and then mixed with other powders of the same size to ensure uniformity in the mixture. After mixing, the powder is placed in an oven at 34-40 degreeC centigrade	Dry or Fusion Method
The source of binding agent is not water of crystallization from the citric acid but the water added to alcohol as moistening agent forming the pliable mass of granulation In this method, all of the powder may be anhydrous as long as water is added to the moistening agent	Wet Method
1) Compare final weight to the theoretical weight Uniformity of color, particle size, flowability, freedom from caking 2) Individually weigh divided powders and compare to theoretical weight Confirm uniformity	1 Quality Control: Bulk Powders 2 Quality control: Divided Powders
Packaging/ Dispensing 1 Bulk oral powders: 2 Divided powders: 3 Topical powders: 4 Insufflations:	1 glass, plastic, metal or other containers that have wide mouth to allow use of powder measure 2 Individually folded 3 Poured into sifter top container or powder shakers 4 Plastic puffer units
1 Granules for reconstitution: 2 They are not swallowed directly 3 complete wetting	1packed in unit of use container, container accomodate typical course of therapy Refrigerated after reconstitution Discard unused contents after specified date 2 Effervescent granules 3 Reconstitution