Suppository Chapter Content

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1 10 min

2 SUPPOSITORY

3 Suppository Chapter Content 1. Suppositories and Factors Affecting Drug Absorption 2. Ideal Suppository and Different Types of Bases 3. Methods of Suppository Manufacturing

4 Suppository Learning Outcome 1. Apply the concept of suppository administration 2. Perform calculations for suppositories using different bases

5

6 Late 14 th Century Suppositorium "To place under"

7 What?

8 Suppository

9 Solid Dosage Form Suppository

10 A suppository is a drug delivery system that is inserted into the rectum (rectal suppository), vagina (vaginal suppository) or urethra (urethral suppository), where it dissolves or melts and is absorbed into the blood stream.

11 A suppository is a drug delivery system that is inserted into the rectum (rectal suppository), vagina (vaginal suppository) or urethra (urethral suppository), where it dissolves or melts and is absorbed into the blood stream. BASE

12 Growth in Suppository Sales WORLDWIDE

13

14 DRUG BASE NOT VERY COMMON DOSAGE FORMS (SUPPOSITORY) PATIENT BASE MELTS DRUG RECTAL FLUID SOLUTION ABSORPTION

15 DRUG BASE NOT VERY COMMON DOSAGE FORMS (SUPPOSITORY) PATIENT BASE MELTS DRUG Zoom RECTAL Shape FLUID 1 SOLUTION ABSORPTION

16

17

18 MUCOSA

19 MUCOSA RECTUM RECTAL FLUID DRUG

20 SINK CONDITION ALLOWS CONTINOUS PASSIVE DIFFUSION

21

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23 SINK CONDITION ALLOWS CONTINOUS PASSIVE DIFFUSION

24 CLASSIFICATION APPLICATION RECTAL URETHRAL VAGINAL USE LOCAL SYSTEMIC

25 LOCAL EFFECT Glycerin Suppository CONSTIPATION

26 Irritates the RECTAL MUCOSA Peristalsis Movement of contents in GI

27 EASY to ADMINISTER INDICATIONS

28 Reasons for choosing Rectal Route

29 Patient not able to use Oral route Drug not suitable for Oral administration

30 Patient not able to use Oral route Unconscious

31 Gastrointestinal Problem

32 Indigestion

33 Mentally disturbed

34 Very Young and Old Patients

35 Drug not suitable for Oral administration Zoom Shape 1 Gastro Intestinal Side effects

36

37 ULCER BLEEDING

38 Drug not suitable for Oral administration Gastro Intestinal Side effects

39 Drug not suitable for Oral administration Unstable in stomach ph

40 High FIRST PASS METABOLISM

41 High FIRST PASS METABOLISM

42 High FIRST PASS METABOLISM

43 High FIRST PASS METABOLISM

44 High FIRST PASS METABOLISM

45 RECTAL IRRITATION & SENSATION

46 RECTAL IRRITATION Rectal Fluid Zoom Shape 1 DRUG

47

48 IRRITATION BODY NATURALLY COUNTERS THIS IRRITATION WATER MOLECULES SENSATION

49 RECTAL IRRITATION & SENSATION Rectal Fluid DRUG

50

51 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

52 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

53 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

54 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

55 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

56 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

57 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

58 Physicochemical characteristics of drug Quantity of rectal fluid Properties of Rectal Fluid The presences of surface active agents Factors Particle Size of the drug Dissolution of slightly soluble substance The suppository is expelled or not

59 Sensation Irritation Quantity of Rectal Fluid Zoom Shape 1

60

61 2-3 ml DRUG particles do not dissolve

62 Sensation Irritation Quantity of Rectal Fluid

63 Dissolution of Slightly Soluble Substance PROCESS OF ABSORPTION DRUG (Hydrophilic) ABSORPTION DISSOLUTION Crossing the RECTAL MEMBRANE

64 Dissolution of Slightly Soluble Substance PROCESS OF ABSORPTION DRUG (Hydrophilic) ABSORPTION DISSOLUTION Crossing the RECTAL MEMBRANE

65 Dissolution of Slightly Soluble Substance PROCESS OF ABSORPTION DRUG (Hydrophobic) ABSORPTION DISSOLUTION Crossing the RECTAL MEMBRANE

66 DISSOLUTION Crossing the RECTAL MEMBRANE

67 DISSOLUTION RATE LIMITING STEP Crossing the RECTAL MEMBRANE

68 DRUG Combinations HYDROPHILIC 4 BASE HYDROPHOBIC

69 It is the DRUG that undergoes ABSORPTION and NOT the BASE

70 MAKE THE FOUR COMBINATIONS AND TELL THE RATE LIMITING STEPS

71 DRUG BASE RECTAL MEMBRANE RECTAL FLUID

72 COMBINATIONS NATURE SAME MEANS NO RLS HYDROPHILIC (Hp) HYDROPHOBIC (Hb)

73 DRUG Hp Hb BASE RECTAL MEMBRANE RECTAL FLUID Hp

74 Drug (Hydrophilic) ABSORPTION Base (Hydrophobic) SLOWEST =RLS

75 Drug (Hydrophilic) Base (Hydrophobic) SLOWEST =RLS

76 Drug (Hydrophilic) Base (Hydrophobic) SLOWEST =RLS RLS

77 Properties of Rectal Fluid Viscosity Surface Tension Zoom Shape 1 Zoom Shape 1

78 Zoom Shape 1

79 VISCOSITY > ABSORPTION

80 Properties of Rectal Fluid Viscosity Surface Tension

81 ST > Ab

82 Properties of Rectal Fluid Viscosity Surface Tension

83 Particle Size of the drug

84 Absolute Surface Area Effective Surface Area

85

86 STABILITY ESTERASE PEPTIDASE Stability of Peptide-like Drugs

87 Physicochemical Characteristics of Drug that Affect its Absorption Lipid Water Partition Coefficient

88 OIL AQUEOUS Ko/w DRUG HYDROPHILIC

89 Important Points Rancidity in fats increases the iodine value Water number can be increased by the addition of surfactants Good suppository base has low acid value or no acids

90 Decomposition with Acid, moisture or oxygen

91 Characteristics of Ideal Suppository Bases

92 Suppository Bases Suppository bases are agents into which the drug is incorporated when in a molten state and then solidified to form the suppository.

93

94 IDEAL SUPPOSITORY BASES Melts at 37.5 o C (rectal temp) or dissolve in body fluids

95 Non toxic, Non sensitizing, or Non irritating to sensitive or inflamed tissues

96 Compatible with a broad variety of drugs

97 No meta stable forms

98 No meta stable forms

99 Solidify quickly after melting

100 Easily molded & easily removed from the mold

101 Release the active ingredient readily

102 High water no.- Increase % of water or solutions that can be incorporated

103 Chemically stable

104 Easy to handle

105 For fatty bases, Acid value is below 0.2 Saponification value ranges from 200 to 245 Iodine value is less than 7 Low interval between melting point and solidification point

106 Function of Suppository Bases Dilute the drug to non irritating level Control the rate of drug release Represent the drug in an acceptable, usable form

107 Types of Suppository Bases Identified by the USP Cocoa Butter Cocoa Butter Substitues Glycerinated gelatin bases Polyethylene glycol bases Surfactant or water-dispersible bases Tableted suppositories or inserts

108 Advantages of Suppository Accurate dosage forms

109 Good, when oral dosage forms cannot be taken

110 Drugs sensitive to the gastric ph and gastric enzymes

111 Drugs irritating to the stomach

112 Useful in Nausea and vomiting

113 LOCAL EFFECT

114 Faster Onset of Action

115 May Bypass First Pass Hepatic Metabolism

116 Disadvantages of Suppository Patient acceptability

117 Not suitable for patients suffering from diarrhea

118 Dose can be big and can cause irritation

119 Incomplete absorption as suppository promotes bowel evacuation

120 Different Types of Bases

121

122 Naturally occurring Cocoa Butter (Theobroma oil)

123 Heated above 35 C or solidify at < 15 C Crystalline Polymorphism is the ability of a solid material to exist in more than one form or crystal structure

124

125 Alpha, Beta, Beta prime & Gamma Forms are recognized It is a lower melting point polymorph and will convert to more stable form over time

126 Advantages of Cocca Butter Non reactive & Non irritating

127 At room temperature has a amorphous solid form

128 Melts at C to a non irritating oil

129 Rapidly solidifies when cooled

130 Miscible with many ingredients

131 Disadvantages of Cocca Butter Rancidity due to oxidation of unsaturated glycerides

132 Melt at hot climates Overcome by adding beeswax - 10%

133 Liquefy with certain drug

134

135 Liquefy with certain drug

136 Overheating leads to isomerization

137 Insufficient contraction at cooling

138 Low softening point, chemical instability

139 Poor water-absorptive power

140 Expensive

141 Susceptible to oxidation

142 (need a something more hydrophilic)

143 Adhesion or sticking to the mold

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