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
22
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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