- consist sugar mainly of sucrose that is processed to have ppts suitable for direct compression.
- contain small qt. of dextrin, starch @ invert sugar
- whte crystalline powder w/ sweet taste & complete H20 solubility
- require incorporation of suitable ;ubricant at normal levels for lubricity
- sugar usedly for chewable vit. tab. b/c of natural sweetness
- Partial @ compl. separation of top @ bottom crowns of tab. from the ain body of tab.
- adhesion of tab. material to a die wall. result from excessive moisture @ subs.w/ ⬇melting temp. in formulation
- Separation of tab. into 2 @ ⬆ distinct layers. Result from air entrapment during processing
- removal of tab.surface
material by a punch
- Unequal color distribution on tab, w/ light @ dark areas standing on otherwise uniform surface
- Result from use of drug w/ color diff. from that of tab. excipients @ from drug w/ color degraded products
- Consist of compressing tab. directly from powdered material w/o modifying the physical nature of material itself
- Direct compr. for tab. containing 25% @ ⬇ subs.frequently can be used by formulating w/ suitable diluent which act as carrier @ vehicles for drug
- These ppts impated to them by processing step such a wet granulation, slugging,spray drying @ crystallization
- Most widely used & general method.
- Advantage: improve powder flow, ensure uniformity of content & improve compressibility to get good tab.
- Disadvantage : no. of separate steps involved, as well as time & labor necessary to carry out the procedure, especially on large scale
1-weighing,2-mixing,3-granulation,4-screening damp mass,5- drying, 6-dry-screening, 7- lubrication, 8-compression
- active ing., diluent & disintegrant are mixed @ blended well
- The powder blend sifted through screen to remove @ break up lumps, this affords additional mixing
- Eliminates a no. pf steps but still include weighing, mixing, slugging, dry screening, lubrication & compression.
- Active ing, diluent & part of the lubricant are blended
- Powdered materials contains considerable amunt of air, under pressure, this air is expelled & fairly dense piece is formed. The ⬆ time allowed for this air to escape, the better the tab. @ slug
- compressed slug go through the desirablemesh screen either by hand, @ for larger quantities through communiting mill
- Lubricant remaining added to granulation, blended and compressed into tab.
- Aspirin is good ex where slugging is satisfactory
-Thickness can vary w/ no change in weight due :
- Diff. in the density of granulation
- The pressure applied to tab.
- The speed of tab. compression
+- 5% may allowed, depending size of tab.
- In vitro only
- useful as quality-assurance tool for conventional (non-sustained release) dosage forms
- The basket rack immersed in a bath, 37 , 1L beaker
- uncoated tab. 30 min. coated tab. up to 2hrs. Sublingual tab. 3 min.
-Determine the tab. is slowly @ poorly soluble drug.
- measure amount of time required for given % of the drug subs in tab. to go into soln. under a specified set of conditions is an in vitro test
- provide step towards evaluation physiological availability of drug subs but not designed to measure safety of tab. being tested
- provide vitro control produce to eliminate variations among prodxn batches.
- amount of drug dissolve x leh < than 70% of quantity contained in tab. after 45 min.
GENERAL APPEARANCE Imp.for:
1) consumer acceptance
2) lot-to-lot uniformity
3) tab-to-tab uniformity
4) monitoring of the manufacturing process
- control of appearance includes measurement of such attributes size, shape, color, odor, taste, surface, textures physical flaws,consistency.
- to withstand the mechanical shocks of manufacture, packaging, & shipping
- Ensure consumer acceptance
- Hardness relate both tab. disintegration & drug dissolution.
- Tab. hardness testers measure degree of force in kg required to break a tab. across the diameter
- Determine friability by allowing tab to roll & fall within a rotating tumbling apparatus. The tab. weighted before and after 100 no. rotations, & the weight loss is determined
- Resistance to weight loss - tab. ability withstand abrasion during handling, packaging,shipping
-compressed tab. that lose < than 1% of their weight are generally considerable acceptable
UNIFORMITY OF DOSAGE FORM
- Weight variation ; tab. containing 50mg @ > of drug subs. in which drug subs reresent 50% @ > (by weight) of dosage form limit
- Further 20 tab. assaye d all must fall within 85-115%