Suppositories: Displacement value, Packing and storage, Evaluation methods, IP products and MCQs for GPAT, NIPER, Pharmacist and Drug Inspector exam

Suppositories: Displacement value, Packing and storage, Evaluation methods, IP products and MCQs for GPAT, NIPER, Pharmacist and Drug Inspector exam

Displacement value: The quantity of the drug which displaces one part of the base is known as displacement value.

Example – Determination the displacement value of a medicament in theobroma oil suppositories containing 40% medicament, prepared in 1 gm mould. The weight of 10 suppositories is 14.66 gm.

Solution: 1. Wt.of 10 suppo. Cont. theobroma oil alone prepared in 1 gm capacity mould=1 x 10=10 gm

  1. Wt.of 10 suppo. Cont. 40% of medicament = 14.66gm
  2. Amt. of theobroma oil present = 60/100 x 14.66=8.79 gm
  3. Amt. of medicament present = 40/100 x 14.66= 5.86 gm
  4. Amt. of theobroma oil displaced by 5.86 gm of medicament = 10 – 8.79 = 1.20 gm

So, Displacement value of medicament = 5.86/1.20 = 5

Packing and storage: Suppositories are usually packed in tin or aluminum, paper or plastic. Poorly packed suppositories may give rise to staining, breakage or deformation by melting. Both cocoa butter and glycerinated gelatin suppositories stored preferably in a refrigerator. Polyethylene glycol suppositories stored at usual room temperature without the requirement of refrigeration.

Evaluation methods:

SURFACE APPEARANCE AND SHAPE: To evaluate absence of fissuring, absence of migration of active ingredient, absence of pitting, absence of fat blooming (dullness of surface).

MELTING RANGE TEST:

Macro-melting range: measures the time it takes for the entire suppository to melt when immersed in a constant temperature (370C) water bath.

Micro-melting range: is the melting range measured in capillary tubes for the fat base only.

The apparatus used for measuring the melting range of the entire suppository is a USP tablet disintegration apparatus.  The suppository is completely immersed in the constant temperature water bath, and the time for the entire suppository to melt or dispense in the surrounding water is measured. The in-vitro drug release pattern is measured by using the same melting range apparatus.

LIQUIFACTION OR SOFTENING TIME TESTS OF RECTAL SUPPOSITORIES: The “softening test” measures the liquefaction time of rectal suppositories are an apparatus that simulate in-vitro conditions (at 37oC).

BREAKING TEST: It is designed as a method for measuring the fragility or brittleness of suppositories. The apparatus consists of double-wall chamber in which the test suppository is placed. Water at 37oC is pumped through the double walls of the chamber, and the suppository, contained in the drug inner chamber, supports a disk to which a rod is attached. The outer end of the rod consists of another disc to which weights are applied.

MECHANICAL STRENGTH: It is a force necessary to break a supp. And indicate whether supp is brittle or elastic. ( not less than 1.8-2 Kg) by Erweka method.

MELTING & SOLIDIFICATION: It can be determine by using evacuated flask into which the melt is placed, the temp of cooling is noted to determine the solidification point.

DISSOLUTION TESTING: The patterned is measured by using the same melting range apparatus. If the volume of water surrounding the suppository is known, then by measuring aliquots of the water for drug content at various intervals within the melting period. A (time versus drug release) curve could be established and can be plotted.

IP product:

Bisacodyl –

Commercial product : Dulcolax
Active constituent : 10mg
Type of effect : Local
Category and Comments : Cathartic. Base: hydrogenated vegetable oil

Multiple choice questions:

1.The quantity of the drug which displaces one part of the base is known as

a)displacement value

b)base value

c)displaced value

d)all of these

2.Suppositories are usually packed in

a)tin

b)aluminum

c)paper

d)all of these

3.Poorly packed suppositories may give rise to

a)staining

b)breakage

c)deformation

d)all of these

4.Which of the following suppositories are stored preferably in a refrigerator?

a)cocoa butter suppositories

b)glycerinated gelatin suppositories

c)both of these

d)none of these

5.Which of the following suppositories are stored at usual room temperature without the requirement of refrigeration?

a)Polyethylene glycol suppositories

b)cocoa butter suppositories

c)glycerinated gelatin suppositories

d)all of these

6.Which of the following is not an evaluation method for suppositories?

a)surface appearance and shape

b)melting range test

c)breaking test

d)leaker test

7.Fat blooming means

a)dullness of surface

b)shiny surface

c)breaking of suppositories

d)none of these

8.Melting range test for suppositories include

a)Macro-melting range

b)Micro-melting range

c)Both of these

d)None of these

9.The “softening test” measures

a)breaking of suppository

b)mechanical strength of suppository

c)liquefaction time of rectal suppositories

d)all of these

10.It is designed as a method for measuring the fragility or brittleness of suppositories.

a)mechanical strength

b)breaking test

c)melting & solidification test

d)softening time test

11.Mechanical strength test indicates

a)brittleness of suppository

b)elastic of suppository

c)breaking of suppository

d)a and b

12.Which of the following method is used to determine mechanical strength of suppository?

a)Andreasen pipette

b)Erweka method

c)Flash point method

d)None of these

13.The curve plotted for dissolution testing in evaluation of suppositories is between

a)time versus drug release

b)temperature versus drug release

c)amount of base used versus drug release

d)all of these

14.Surface appearance and shape test is done to evaluate absence of fissuring, absence of migration of active ingredient, absence of pitting, absence of fat blooming.

a)true

b)false

15.Macro-melting range is the melting range measured in capillary tubes for the fat base only.

a)true

b)false

Solutions:

  1. a)displacement value
  2. d)all of these
  3. d)all of these
  4. c)both of these
  5. a)Polyethylene glycol suppositories
  6. d)leaker test
  7. a)dullness of surface
  8. c)Both of these
  9. c)liquefaction time of rectal suppositories
  10. b)breaking test
  11. d)a and b
  12. b)Erweka method
  13. a)time versus drug release
  14. a)true
  15. b)false

References:

  1. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 10th edition, page no. 367, 384, 385.

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