1. Active ingredients contentin each dosage form must bebetween _____-______% oflabel claim for ___ out of 10doses.

85-115% for 9 out of the 10doses.

2. Advantage of Coni-snap tapered rim of capsule bodyprevents the denting orsplitting during highcapacity filling

3. All powders have differentdensities andcompressibility

A size 5 capsule may fit 60-130 mg of powderdepending on the specificfill material.

4. Amount of fill material isdetermined by its densityand compressibility.

...

5. Bloom Strength Empirical measure of gelstrength; measured inBloom gelometer.

Indicates the weight ingrams required to depress astandard plunger 4 mm intothe surface of a 6.67% gel

6. Bone gelatin contributes tofirmness

Type B

7. calcium stearate lubricant

8. Caps and bodies may bemade a different color inhard gelatin capsule shells

But all capsules must beFDA approved.

9. Capsule Means small box orcontainer

10. Capsule disintegration test: Basket of glass tubes withboth ends open and wirescreen put capsule in tubeand lower 29-32 cycles perminute in a liquid.

The disintegration times arespecified in specificmonographs for eachcapsule

The capsules shoulddisintegrate into a softmass.

11. Capsule DisintergrationTest

Different for sustainedrelease capsules than fornormal capsules.

12. Capsule filling machine Automated processwhich may produce 200-2000 capsules per houror up to 165,000 capsulesper hour.

13. Capsule shape where only thebody is tapered not the cap

Bullet shape; pulvules

14. Capsules solid dosage forms inwhich the drug isencoded within a hard orsoft soluble container orshell

15. Capsules are a poor choice fordrugs that are ______ or_____

Extremely soluble

Insoluble: have a lowsolubility and littledispersion will preventdisintegration.

16. Coni-snap shape of a capsule thatcontains lockinggrooves; hard to open

17. Content Uniformity Test:Batch to batch

1. Assay 10 capsulesindividually for drugcontent2. Active ingredientscontent in each dosageform must be between85-115% of label claimfor 9 out of 10 doses.3. No unit should beoutside 70-125% range(for the one dose)

18. croscarmellose disintergrants

19. Desiccant used to package capsules;used to absorb waterex: dried silica gel or clay

20. Diluents lactosemicrocrystalline cellulose

21. disintegrants pregelaninized starchcaroscarmellosesodium starch glycolate

22. Dissolution of drug instimulated gastric fluid withlubricant vs. no lubricant.

The dissolution rate ofdrugs with lubricantdissolves SLOWER thandissolution rate of drugswithout lubricant.

23. Every change, particle size, orcomponent used in themanufacturing of a drug,blending times will all affectthe ______________.

Dissolution rate of a drugin the stomach.

Capsules: A Dosage FormStudy online at quizlet.com/_3zgjh

24. Feton Capsule FillingMachine (small-scale

1. Loader tray placed on the fillerunit.2. Top plate is removed to separatecaps from bodies3. Capsule bodies are filled withpowder4. Top plate is returned andcapsules placed on filled bodies.5. Capsules are cleaned.

25. Filled capsules arenormally swallowedwhole; who may breakcapsules open?

Filled capsules are normallyswallowed whole. Caregivers mayopen the capsule and mix the drugwith food or drink.

26. Fluid Fluid may be sprayed onto thejoints between capsules to seal.

27. Gelatin NF Partially hydrolyzed collagen ofanimal skin, connective disuse andbones.

28. Hard Gelatin CapsuleShells

Composed of gelatin, sugar, andwater. Capsules are clear or opaque; butcolor may be added.

29. Hard GelatinCapsules is a versatilecontainer; may placecapsule, tablet,powder, liquid, orsemi-solid inside.

...

30. High concentrationmagnesium stearatevs. low concentrationof magnesiumstearate

A higher concentration ofmagnesium stearate will have alower amount of drug dissolved,than a low concentration ofmagnesium stearate which willhave more drug dissolved.

31. How are hard gelatincapsulesmanufactured?

Hard gelatin capsules aremanufactured all by an automaticprocess:1. Pegs (500/plate) are submergedto a desired depth for a certainperiod of time.2. Pegs withdrawn and dried in acontrol environment.3. Capsules are trimmed to adesired length4. Bodies are joined to the caps

32. How is batch to batchconsistency for hardcapsule weight tested?

Test for hard capsule:1. Weigh 10 capsules individually2. Remove content3. Weigh empty capsules4. Determine weight of the contentsby subtraction.

33. How is batch to batchconsistency for softcapsule weight tested?

Test for soft capsule:1. Weigh 10 capsules individually2. Cut open the capsule3. Remove contents by washingthem with a solvent4. Allow solvent to evaporate for30 minutes.5. Weigh the empty shells 6. Determine the weight of thecontents

34. How should capsulesbe dispensed?

Should meet USP specifications

May be required to be liquidresistant, tight and well closed.

35. If you have a highconcentration ofmagnesium stearateyou must add________ _____.

A wetting agent; becausemagnesium stearate is alubricant. If you don't add awetting agent you are affectingthe drug dissolution.

36. In capsuledisintegration test, thecapsules should__________.

Disintegrate into a soft mass

37. In content uniformitytest, no unit should beoutside ____ to ____ %for the one dose.

70-125%

38. Is gelatin stable?unstable?

Gelatin is stable in the dry form;and may absorb water

Gelatin is biodegradable; digestedby proteolytic enzymes.

39. lactose diluent

40. liquid gelatin flowing form anoverhead tank forms two ribbons,which are fed between twin rotarydies that continually open and closeto form pockets in the ribbons, thepockets are filled with the drug,capsules are sealed and shaped andcut.

Rotary methodfor soft capsule

41. Lubricant needed for thefree-flow ofpowder fromhopper intocapsule shell; if awaterprooflubricant is usedit will be slowerdissolution ratein the drug.

42. lubricants magnesiumstearatecalcium stearate

43. Made of gelatin, containing glycerinor polyhydric alcohol (sorbitol)

Soft gelatincapsule

44. Magnesium stearate a lubricant

45. magnesium stearate lubricant

46. Market Availability of Capsules Doesn't coincidewith patientpreference

1. Tablets most 2. Hard gelatincapsules3. Soft Gelatincapsules least

47. Medicated capsule used in clinicaltrial

Hard GelatinCapsule shell

48. Method used to make capsules on asmall scale. The powder to be filled isformed into a cake to a depth equal to1/4th or 1/3rd of the length of thecapsule body. The capsule body isinverted and punched repeatedly intopowder until filled. The cap is addedand weight is checked.

Punch method

49. microcrystalline cellulose diluent

50. microionized powder greater than 10um and can aidin distributionand affect powderdensity

51. On a small scale, how arecapsules sealed?

Capsules on a smallscale are sealed by:coating the innersurface of cap withwarm gelatin betweenthe cap and body.

52. ONE-PIECE DOSAGE FORM Soft gelatin capsules

53. Patient Preference of Capsules Doesn't coincide withmarket availability:Most preferred1. Soft gelatin capsules2. Tablets3. Hard gelatincapsulesLeast preferred.

54. Pegs for the ______ are larger indiameter than the pegs for the______ of the capsule. (body orcap)

CapBody

55. Pharmacist should aware thedifferences of generic and brandcolor and shape to the patient

...

56. Pork skin gelatin contributes toplasticity and clarity to givedistinct color and shape

Type A

57. pregelatinized starch disintergrants

58. Pulvules Bullet shape capsuleachieved by thetapering on the bodybut not the cap

59. Sealing agent Used in location wherethe cap and the bodymeet.

60. Similar particle size and densityof a drug and non drugcomponent permits _______________ __________.

Uniform drugdistribution

61. SIZE OF CAPSULE DEPENDSON:

The size of the capsuledepends on the dosagerequired to fit in thecapsule.

1. must select propercapsule size2. then trial and errorafter estimate for afinal determination ofproper capsule size.

62. sodium lauryl sulfate wetting agent

63. sodium starch glycolate disintergrants

64. Soft Gelatin Capsules Small, soft, oblong, oval orround and easy to swallow.One-piece sealed dosage form.

65. Spansule shape of capsule where bothends are tappered

66. Substances may be addedto a capsule if: (4requirements)

1. They are not harmless2. Do not exceed minimumamounts required to producetheir effect (i.e color)3. Do not impair the productssafety or bioavailability.4. Do not interfere withcompendia tests.

67. T/F: Gelatin Capsules aresusceptible to microbialdecomposition.

T: Capsules are susceptible tomicrobial decomposition.

68. Type A Gelatin Acid processing of pork skinPI 7.0-9.0

69. Type B Gelatin Alkali processing of bones andskinpI 4.8-5.0

70. Used by dispensingpharmacist in theextemporaneouscompounding ofprescriptions; preparedosage from powder.

hard gelatin capsule shell

71. Uses a set of molds forproduction of soft gelatincapsules

plate method for soft gelatincapsule production

72. Viscosity of gelatincapsules

Determines what type ofcapsule will be produced

73. Water Content in a HardGelatin Capsule

13-16% water; if it loses waterand contains less than 5%water then it will make thembrittle.

Capsules may loose water instoring in a dry area to makethem brittle.

74. Water content in a hardgelatin capsule >16%

Water content in a hardcapsule greater than 16% willcause capsule distortionbecause the moisture isabsorbed upon storage in highhumidity.

75. wetting agents sodium lauryl sulfate

76. What are capsules sealedwith?

KapsealsHeat welding-fuses cap to bodyThermal bonding of low tempmelting additive-40-45

77. What are differentways to fill capsules?

Capsules may be filled two ways: alarge-scale and small-scaleapproach.

1. Punch method (small-scale)2. Capsule filling machine (large-scale)

78. What aredisadvantages ofcapsules?

May irritate esophagus (especially inlarger capsules)

Sensitive to humidity changes (bc ofwater content in them)

Poor choice for drugs that areextremely soluble or insoluble

79. What are possibleproductionproblems incapsules?

Lack of control of drug particle sizemay change how the drug isabsorbed.

Blending variations may affectcontent uniformity and dissolution-->the amount of lubricant may havean affect.

80. What are propertiesof gelatin forsolubility?

Gelatin is:Insoluble in cold water (won'tdisintegrate)Soluble in hot water (gastric fluidwill dissolve)Soluble in warm gastric fluids

81. What are thedifferent types ofgelatin?

Two types of gelatin used in capsules1. Type A Gelatin 2. Type B Gelatin

82. What are theformulation stepsfor capsules?

1. Define the drug: proper chemicalmodification, particle size2. selection of additives: filler,wetting agent, lubricant3. identify proper capsule size4. blend ingredients: especially forlow doses5. fill, close and clean capsules6. check weight

83. What are the goals ofcapsule formation?

1. provide accurate dosage2. insure good bioavailbility3. ease of production (to keep costdown)4. good stability for a long shelf life5. attractive appearance

84. What are the mostcommerciallyavailable medicatedcapsule?

Hard gelatin capsule shell; morecommon than soft gelatin capsule.

85. What are two mainphysiochemicalproperties of gelatincapsules?

1. Bloom Strength2. Viscosity

86. What is a desirablebloom strength?

150-280 grams

87. What is Coni-snapsupro?

Coni-snap supro is designed toprevent easy opening of the filledcapsule; it increases security of thecapsule. Cap is much longer than in coni-snap to fit more over the entire bodyto make them taper-evident.

88. What is gelatincapsules composedof?

Gelatin capsules usually a mixtureof Type A and Type B gelatin.Type B: bone gelatin contributes tofirmnessType A: pork skin gelatincontributes to plasticity and clarity to give distinctcolorand shape.

89. What is hard gelatincapsule composed of?

Two parts:1. Cap2. Body

90. What is theadvantage of usingKapseals?

Kapseals are sealing with a coloredbrand of gelatin.

Advantage: if band is broken, it isvisible and it may not be tamperedwith.

91. What is the purposeof capsule sealing?

Joints of capsules are sealed tomake capsules tamper-evident

92. What is the qualitycontrol for capsules?

Capsules must meet the qualitystandards

Product consistent with the labelclaim

Batch to batch consistency

93. What is the taste ofgelatin?

ADVANTAGE: Gelatin isTASTELESS

This allows a powder to beconcealed within a capsule and thepatient will not have any taste.

94. What liquids aresuitable for softgelatin capsules?

Water immiscible volatile andnonvolatile liquids (vegetable oil,aromatic hydrocarbons, ethers,ester, alcohols)

Water-miscible nonvolatile liquids(polyethylene glycol or propyleneglycol)

95. What methodsare used toproduce softgelatincapsules?

Soft Gelatin capsules are produced by:1. Plate method 2. Rotary Method

96. What particlesize should beused forcapsules?

The size of particles may be reducesthrough milling.

97. What shouldbatch to batchconsistency betested for?

1. Capsule Weight2. Content uniformity3. Disintegration

98. When isdisintegrationextremelynecessary?

Disintegration is necessary for immediaterelease products.

99. When is thepunch methodnot useful?

The punch method is not useful for anyimportant potent drug, because the exactdose is not achieved in this small scalemethod.

100. Whichcontains ahigher watercontent: hardor soft gelatincapsules?

Soft gelatin capsules contain a muchhigher water content, which may promotemicrobial growth. So soft gelatin capsulesrequire a much higher antimicrobialpreservative than hard gelatin capsules.

101. Which has alargerdiameter: capor body?

The cap has a larger diameter so it can fitover on the outside of the body of thecapsule.

102. Who inventedgelatincapsules?

Gelatin capsules were invented by Dublancand Mothes in 1834; in which capsule wasprimarily derived from gelatin

103. Why areparticlescleaned?

Particles are cleaned because no powdershould be on the outside of the capsule; donot want to taste anything.

104. Why is a tabletor capsuleplaced withina capsule?

If a tablet is not coated and the taste is adisadvantage, the tablet may be placedinside a tasteless capsule.

105. Why is contentdisintegrationimportant?

Content disintegration is important for thedrug to become available for absorption.

106. Why may atablet orcapsule beplaced withina capsule?

May be used in comparative bioavailabilitystudiesMay be used to separate chemicallyincompatible ingredientsGive modified drug release

107. Z-Weldsgelatin

Fuses the two halves of the body and captogether to create a one-piece capsule:thermal bonding.