A suppository is a solid dosage form in which one or more APIs are dispersed in a suitable base and molded or otherwise formed into a suitable shape for insertion into the rectum to provide local or systemic effect

1. By: Davinder Blagan
BS Pharmacy 3rd year
South-SEED LPDH College

3. Definition
 From Latin word “Supponere” meaning to
place under as derived from sub(under)
and ponere (to place)
 A suppository is a solid dosage form in
which one or more APIs are dispersed in a
suitable base and molded or otherwise
formed into a suitable shape for insertion
into the rectum to provide local or
systemic effect.

4. Reasons for employing
suppositories
 Promote defecation
 Introducing drugs into body
 Treat anorectal disease

5.  Rectal suppositories:are usually 1.5 inch long, are
cylindrical and hav one or both ends tapered. they
have bullet ,torpedo or little finger shape.
 Vaginal inserts formerly called suppositories or
pessaries are globular, oviform or cone shaped and
weigh about 5g when cocoa butter is the base.
 Urethral inserts aka bougies are pencil shaped
suppositories intended for insertion into the male or
female urethra.

6. Rectal Suppositories
Suppository Commercial
product
Category
Bisacodyl Dulcolax(B0ehring
er ingelheim)
Cathartic
Base: hydrogenated
vegetable oil
Hydrocortisone Anusol-HC (Salix) Pruritis ani or
another
inflammatory
condition of
rectum
Hydromorphone Dilaudid(Purdue
Pharma)
Analgesic
Promethazine Hcl Phenergen(Wyeth) Anti histamine,
anti emetic,
sedative.

7. Vaginal inserts
Product
(manufacturer)
Active
constituents
Category
Cleocin inserts(
Pfizer)
Clindamycin
phosphate
Bacterial vaginosis
Monistat7 inserts
(Personal products)
Miconazole nitrate Antifungal for local
vulvovaginal
candidiasis
Semicid vaginal
contraceptive
inserts (white hall
robins)
Nonoxynol-9 Non systemic
reversible birth
control

8. Advantages
 Avoid first pass effect
 Drug stability- prevention from gastric degradation
 Large dose drugs than oral administration
 Avoid irritation in gastric or oral mucosa
 Avoid unpleasant taste
 In children: bitter taste of oral medication or injection
 Patient is unconscious or experiencing nausea and
vomiting
 Rapid drug effect systemically

9. disadvantages
 Defecation may interupt the absorption
 The absorbing surface area of the rectum is much
smaller than the that of the small intestine
 Degradation of some drugs by the microflora present
in the rectum
 The bullet shaped suppository after insertion can leave
the anorectal site and ascend to the rectosigmoint and
dscending colon.
 The fluid content of the rectum is much less than that
of the small intestine which may affect dissolution
rate.

10. PREPARATION
 Molding-from a melt –small scale and industrial scale
 Handrolling and shaping

11. molding
 A. melting the base
 B. incorporating any required medication
 C. pouring the melt into molds
 D. allowing the melt to cool and congeal into
suppositories
 E. removing the formed suppositories from the mold
 Cocoa butter, glycerinated gelatin, polyethylene glycol
and most other bases are suitable for preparation by
molding

12. Suppository molds
 Commercially available molds can produce individual
or large number of suppositories of various shapes and
size.
 Molds are made from stainless steel ,aluminium brass
or plastic
 Care must be exercised in cleaning the molds, as any
scratches on the molding surfaces will take away from
the desired smoothness of the suppositories. Plastic
molds are specially prone to scratching.

13. Lubrication of the molds
 Suppository molds may require lubrication before the
melt is poured to facilitate clean and easy removal of
the molded suppositories
 Lubrication is seldom necessary when the base is
cocoa or polyethlene glycol as they contract on cooling
to separate from inner surfaces and allow easy removal.
 Mineral oil can be used in lubricating

14. Calibration of the mold
 The pharmacist should calibrate eacg suppository
mold for the usual base so as to prepare medicated
suppository each having the proper quantity of
medications.
 The first step in calibration is to prepare molded
suppository from base material alone. After removal
from mold they are weighed and the total and average
weight of each suppository is recorded .to determine
volume the suppository are melted in a calibrated
beaker and the volume of the melt is dtermined for the
total number as well average of one suppository

15. Preparing and pouring the melt
 At least possible heat the weighed supposittory base is
melted over a water bath
 Medical substances are incorporated into a portion of
melted base by mixing on a glass or porcelain tile with
a spatula.
 After incorporation this material is stirred into
remaining base which has been allowed to cool
 The melt is poured carefully into the cavity of the
mold.
 Silica gel can be added to suspended the active
ingredient
 When the suppository are hard they are removed from
the refrigerator.and allowed to come to room
temperature. And the suppository are dislodged.

17. Manufacturing
 Manufactured suppositories are generally prepared by
the melt fusion method.
 The primary packaging of suppository in the
automated process is composed of five distinct stages.
Forming, Dosing , cooling , Sealing and finishing.

18.  The forming process determines the shape and
volume of the mold .
 Once the shells are formed the move to the
dosing statin
 Filled shells are moved to the cooling tunnels.
 Once the solidified suppositories leave the
cooling tunnel ,they move to the sealing area
where the open top of the mold is closed.
 The finishing of the suppositories includes the
perforation, notching and cutting the molds into
the appropriate count strips. The cutting of the
strip length allows for the suppository to be
placed in the final cartons for distribution.

19. Packaging and storage
 Glycerin and glycerinated gelatin (stored at 20-
25C) suppository are packaged in tightly closed
glass container to prevent a change in moisture
content.
 Cocoa butter base suppository are individually
wrapped to prevent contact and adhesion. Stored
below 30C. Refrigerator –(2-8C)
 Light sensitivity drugs are wrapped in an opaque
material such as metallic foil.
 Suppository are also packaged in slide boxes or in
plastic boxes.

21.  Polyethylene glycol base suppository may
be stored at usual room temperature.
 Suppositories stored in high humidity
may absorb moisture and tend to become
spongy, whereas suppositories stored in
places of extreme dryness may loose
moisture and become brittle.

22. Major changes in suppository characteristic due to natural aging and causes.
modification causes examples
odor Fungal
contamination
Suppositories with
vegetable extract
color Discoloration due
to oxidation
Suppositories with
tartrazine yellow
aqueous solution
shape Incorrect
temperature during
storage
Suppository with
essential oil
weight Loss of volatile
substances
Suppositories with
camphor,menthol

23. Expiration date
 To ensure that a drug product meets applicable
standard of identity, strength, quality and purity at the
time of a use , a commercial manufactured suppository
must bear an expiration date determined by
appropriate stability testing .
 If the product is prepared from USP?NF ingredients a
beyond use date of 6 months is appropriate .

24. References
Ansel, H. C., Allen, L. V., & Popovich, N. G. (1999).
Pharmaceutical dosage forms and drug delivery
systems. Philadelphia, PA: Lippincott-Williams &
Wilkins.