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SEMI SOLID PREPARATION
      SUPPOSITORY


    PRESENTED BY
    MANOJ KUMAR
      M.PHARM
  (AMITY UNIVERSITY)
                   Page 1
SUPPOSITORY
 It is solid dosage form meant to be
  inserted into Body cavity like rectum ,
  urethra, vagina, where they melt or soften
  to release the drugs and produce their
  local or systemic effect.

 It is comes under semi solid preparation
 because it is prepared by melting all
 ingredients (bases and other additives
 along with active ingredient).

 All types of suppositories are melt at
  normal body temperature after
  introducing in body cavity and produce
  their effect.                      Page 2
ADVANTANGE OF SUPPOSITORY
 It is the alternated dosage form for drugs
  which have less bioavailability when it is
  taken orally.
 Drugs having bad odour and taste can be
  used in suppository form.
 It is suitable for unconscious patients
  which can not taken drugs orally.
 It is suitable for drugs which produce
  irritating effect in GIT.
 It is suitable for infants and old people
  who find difficulty in swallowing of drugs.
 It is suitable for the drugs which are
  destroyed by portal circulation.
                                     Page 3
DISADVANTAGE OF SUPPOSITORY
 The manufacturing process is more
  difficult as compare other formulation.
 The drugs which cause irritation to
  mucous membrane can not be
  administrated by this form.
 The most important problem is storage
  condition because it stored at low temp.
  (10-20 0c ). Other than the bases get
  liquefied.
 Leakage problem is also most critical
  problem along with suppository after
  introducing in body cavity at elevated
  temperature.

                                    Page 4
TYPES OF SUPPOSITORY


(A)RECTAL SUPPOSITORY-

 It is inserted in the rectal .

 The weight of suppository used in
  children is about 1g and in adult
  about 2g.

   The shape of suppository used in rectal

     is torpedo shape. The length is about 3

                                    Page 5
      cm.
(B) URETHRAL SUPPOSITORY

 The weight of this type suppository is
  about 2g and 60-75 mm long in Females.



 Those intended for males weigh 4 gm
  each and are 100-150 mm long.



 It is available in pencil shape.




                                     Page 6
(C) VAGINAL SUPPOSITORY

 It is in oviform shape.

 It is about 3-5g in weight.

 It is contains the drugs which are used in
  treatment of the infections of female
  genitourinary tract and meant for
  contraception.

 It is contains the combination of
  polyethylene glycol of different molecular
  weights as suppository bases.
                                    Page 7
(D) NASAL SUPPOSITORY
 These suppository are meant for
  introduction into nasal cavity.
 It is about 1g in weight.
 The glycero- gelatin is used as
  suppository bases.


  (E) EAR CONE
 It is also known as AURINARIES.
 These are meant for introduction into the
  ear.
 It is cylindrical in shape.
 It is about 1g in weight.

                                   Page 8
VARIOUS SHAPES OF SUPPOSITORY




                          Page 9
FORMULATION OF SUPPOSITORIES
    (A) SUPPOSITORIES BASES-

    IDEAL PROPERTIES OF SUPPOSITRIES
                BASES-
    The following properties should be required
                for bases---
               Bases should be exist in solid
                form at room temperature.
               It should not irritate and
                produced inflamed sensation in
                body cavity.
               It should be stable during
                storage condition , No change in
                colour, shape , odour.
                                           Page 10
               It should retain hardness and
IDEAL PROPERTIES OF SUPPOSITRY BASES

        It should not reacts with drugs and
         additives.

        It should have good emulsifying and
         wetting property.

        It should have acid value less than 0.2 or
        zero.

        It should have iodine value less than 7.

        It should have sponification no. range
         between200-245.                    Page 11
(1) HYDROPHILIC BASES
(A) WATER DISPERSIBLE BASES-

 These are the mixture of non ionic
  surfactants which are chemically related
  to polyethylene glycol.

 These are used alone or in combination
  with other type of bases.

 Cellulose derivatives like
  methylcellulose, sod.carboxymethyl
  cellulose are also comes under this
  class.

                                   Page 12
Advantages
 They are suitable for both water soluble
  and oil soluble drugs.
 They do not support the growth of
  microbes in the preparation.
 They can be stored at elevated
  temperature.

  Disadvantages-

 This types of bases are interact with few
  drugs and alter the bioavailability of
  these drugs.


                                   Page 13
EXAMPLES

 Polyoxyethylene sorbitan fatty acid
  ester(TWEENS)

 Polyoxyethelene stearates(MYRIS)

 Sorbitan fatty acid esters(SPANS)

 Combination of Tween 61(60%) and
  Tween 60(40%)

 Combination of Tween 61 (85%) and
  glyceryl monostearate (15%)
                                   Page 14
(B) WATER SOLUBLE BASES
 (1) GLYCERO-GELATIN-
  This occurs as a gels
  It is a mixture of gelatin, glycerol, and
     water.
  According to BP the composition of the
     bases –
               GELATIN- 14% w/w
               GLYCEROL– 70% w/w
                WATER– QS

  For gets a stiff mass , the quantity of
   gelatin should be increased to 32.5% and
   reduced the glycerol to 40%.
                                     Page 15
PREPARATION OF GLYCERO-GELATINE
             BASES

    GLYCEROL          WATER        GELATINE




               GLYCERO-GELATINE BASES



                                        Page 16
ADVANTAGES

 Suppository prepared by glycero-gelatin
  bases are strong and translucent unlike
  cocoa butter suppositories.

 This base is disperse slowly in the body
  cavity fluids and provides prolonged
  release and action of drugs.


   DISADVANTAGES-

 It absorbs moisture and promotes
  microbial growth , so this reason
  preservatives are used .          Page 17
DISADVANTAGES

 The bases are show incompatibility with
  protiens prescipitants due to the gelatin

 It causes dehydration and irritation of
  rectal mucosa

 It exerts undesirable laxative action.

 It requires special storage condition at
  about 10-15 0c.

 Handling and manufacturing of these type
  of suppository are difficult.   Page 18
(2) POLY ETHYLENE GLYCOL(POLYGLYCOL)
         It is also called as PASTONALS
          (GERMANY).
         CARBOWAXES(U.S)
         They are long chain polymers of ethylene
          oxide.
         They occur in liquid and solids.
         Liquids have mol.weight about 200-600.
         Solid have mol.weight about more than
          1000.
         They are also called as macrogols.
         They are the mixture of two or more
          grades of macrogols used as
          suppository bases.
                                          Page 19
EXAMPLES

 PEG 4000- 33 parts
  PEG 6000- 47 parts
  PURIFIED WATER- 20 parts

 FOR HARD SUPPOSITORY
  PEG 1000- 75 parts
  PEG 4000- 25 parts

 FOR SOFT SUPPOSITORY
  PEG 1000- 96 parts
  PEG 4000- 4 parts

                             Page 20
ADVANTAGES

 This base is thermostable.

 It does not get degraded or hydrolysed.

 It does not support microbial growth.

 It dose not move out from body cavity
  after introducing.

 It has good water absorbing capacity.

 It is chemically stable.
                                   Page 21
DISADVANTAGES
 It is susceptible to rancidification,so it
  should be stored in dry place away from
  light.
 It melt easily in warm weather,so it
  should stored in cool place in warm
  season.
 Large quantities of water can not be
  incorporated into the bases.So emulsifier
  such as tween 61 (6-10%) are useful to
  increase the absorption of water.
 The physical characteristics of the bases
  are change from batch to batch.
 Some times leakage may be occur after
  introducing in body cavity.
                                    Page 22
(2) LIPOPHILIC BASES
  (a) COCOA BUTTER

 It is natural triglyceride.
 Among all fatty acid about 40% are
  unsaturated fatty acid .
 It can exist in more than one crystalline
  form or exhibits polymorphism.
 At room temperature ,it is yellowish-
  white with a paints,chocolate like odour.
 It consists of a mixture of ester of oleic
  acid,palmatic acid,stearic acid and other
  fatty acid with glycerol.

                                    Page 23
ADVANTAGES


 It is liquified readily on warming and
 sets rapidly on cooling.

 It has emollient effect which is useful to
  relieve inflammation.

 It shows good release of water soluble
  drugs.

 It does not cause irritation in mucous
  membrane.

                                     Page 24
DISADVANTAGES
 It is susceptible to rancidification ,so it
  should be stored in dry place away from
  light.
 It gives soft suppository when
  formulated along with chloral hydrate ,
  phenol, volatile oil, which have lower
  melting point.
 The physical property of the base is vary
  from batch to batch.
 It required extra lubricant during poring
  in holder.
 Some times leakage may be occur.



                                     Page 25
(B) ANTI OXIDANTS

 It is protect the drugs and bases from
  getting degraded due to oxidation.
 These are commonly used in all types of
  suppositories.
   EXAMPLES-
 Ethyl or propyl gallate
 Ascorbic acid
 Butylated hydroxy anisole (BHA)
 Butylated hydroxy toluene (BHT)
 Hydroquinone
 Tocopherol


                                  Page 26
(C) EMULSIFYING AGENTS

 These are increase the water absorbing
  capacity of fatty bases.

 EXAMPLES

 Poly sorbates (TWEEN 61)

 Wool alcohol

 Wool fats



                                 Page 27
(D) HARDENING AGENTS

 These are involved in those formulation
  where the melting point of the bases is
  decrease by the drugs.

 These are the agents which are used to
  bring the melting point to normal.
 EXAMPLES
 Beeswax
 Macrogols at high molecular weight.




                                   Page 28
(E) PRESERVATIVES

 These are the agents which are used in
  prevent the growth of microbial in
  suppository which contains water
  soluble bases.

 EXAMPLES

 Chorocresol

 Methyl paraben

 Propyl paraben
                                  Page 29
(F) THICKENING AGENTS
 These are the agents which are used to
  increases the viscosity of molten bases
  and prevent sedimentation of suspended
  in solid bases.

 EXAMPLES

 Aluminium monostearate
 Colloidal silica
 Magnisium stearate
 Steary alcohol



                                  Page 30
(G) PLASTICIZERS
 These are the agent which are used to
  improved flexibility of suppositories.
 It is also used to make the less brittles
  to suppositories.

   EXAMPLES
   Castor oils
   Glycerine
   Glycol
   Tween 80
   Tween 85


                                      Page 31
METHODS OF PREPARATION OF
      SUPPOSITORIES

     MOLDS USED IN PREPARATION OF
     SUPPOSITORIES-
    Molds used in preparation of
     suppositories are the metals devised with
     different shape.
    It is consists of two or more parts which
     are joined with a screw.
    In side the molds the cavities are made
     up of aluminium , brass, stainless steel ,
     plastics.
    Molds have different capacities like
     1,2,4,8gm.
                                       Page 32
Mold




       Page 33
PLASTICS MOLDS




                 Page 34
CALIBRATION OF THE           MOLDSCC

 The first step is to prepare molded
  suppositories from base material alone.



 The suppository's combined and average
  weight is recorded.



 To determine the volume of the mold, the
  suppositories are melted in a calibrated
  beaker, and the volume of the melt is
  determined.
                                   Page 35
LUBRICANTS USED IN MOLDS
 Cocoa butter and glycero-gelatine bases
  are required lubrication of molds.
 This is prevent sticking of bases to the
  wall of molds cavity.
 It is also useful in easy removal of
  suppositories from the molds.
 The lubricants are form a film between
  the wall of mold cavity and base of
  suppositories so it prevent adhering of
  bases to the molds.
 The nature of lubricants should be
  different from nature of bases.


                                   Page 36
EXAMPLES

(1) FOR COCOA BUTTER BASES

      ALCOHOL(90%)- 50ml
      GLYCEROL     - 10ml
      SOFT SOAP   - 10 gm



(2)   LIQUID PARAFFIN



(3)   ARACHIS OILS
                             Page 37
MANUFACTURING OF SUPPOSITORIES
      Hand molding
      Automatics Machine Molding
      Compression Molding
      Heat Molding


     1) HAND MOLDING-
      Hand molding is useful when we are
        preparing a small number of
        suppositories.
      It is suitable for thermo labile drugs.
      It is more economical methods.
      It is more time consuming and not
        uniformity process.
                                           Page 38
STEPS INVOLVED IN HAND MOLDING

   The drugs and other additives are made
    into a fine powder .

   It is incorporated into the suppository
   base by kneading with it or by trituration
   in a mortar.

   Then these masses are rolled into the
    shape of a cylindrical rod on the rolling
    tile in presence of lubricants to prevent
    the adherence of masses.

   Then cut the rods and made one end to
                                   Page 39
    pointed.
DRUG+ADDITIVES     FINE POWDER

                   MIXED IN BASES

   APPLY LUBRICANTS ON ROLLING TILE

       ABOVE MASSES ARE ROOLED IN

            CYLINDRICAL SHAPE

                     CUT THE RODS

                        PACKED

                        STORED 40
                            Page
(2) AUTOMATIC MACHINE MOLDING
 All the operations in pour molding are
  done by automatic machines.
 Using this machine, up to about 10,000
  suppositories per hour can be produced.
 By this the rate of production of
  suppositories is more higher than hand
  molding.
 In this ,there are no chance of air
  entrapment and contamination of
  suppositories.
 In this ,if any mass deposited in mold is
  not removed during cleaning, so produce
  overweight suppositories with mold
  marks.
                                   Page 41
There are two types of machines used they
   are following---
(a)Rotary Machine-
 The rate of production of suppositories
   are about 3500-6000/hr.
 This machine consists of a turn table in
   which metal molds are fitted.
 This table rotates sequentially, the mold
   gets filled with drug , additives, bases and
   cooled and ejects the suppositories.
 Before mass filled in mold ,the lubricant
   are apply in mold wall.
 The excess mass is removed by the
   scraping unit.
 The cooling system results the
   solidification of suppositories.     Page 42
 After the cooling the mold is moves
  towards ejection station , it consists of a
  stainless steel rod which push out the
  suppositories from molds.
 Then completed the ejection process , the
  empty molds are again moves towards
  the filling unit for further processes.



 STEPS INVOLVED IN PROCESS AS
  FOLLOWING




                                     Page 43
DRUG+ADDITIVES       FINE POWDER

                   MELT BASES + POWER

                       HOPPER

                 LUBRICATED THE MOLDS

          FILL ABOVE MIXTURE IN MOLD

                   COOLING SYSTEM

                   EJECTION SYSTEM

PACKED    STORED                Page 44
(b) LINEAR MACHINE
 It is similar to rotary machine.

 Except the rate of production is more
  higher than rotary machine about
  10000/hr.

 All steps involved is similar to rotary
  machine.

 There is no chance of air entrapment
  and contamination of suppositories as
  similar to rotary machine.
 The rate of production is higher than
  rotary machine.                    Page 45
(3) COMPRESSION MOLDING
  CONSTRUCTION- The compression
   machine consists of a cylinder, piston ,
   molds, and a metallic stop plate at the
   bottom.

  WORKING- When placed the mass in
   cylinder and apply the pressure .
  Then mass fulfill in mold move and s
   remove the suppositories and keep them
   in cool placed.
  After cooling release them from
   compression machine and packed .


                                     Page 46
PROCEDURE
DRUG+ADDITIVES       FINE POWDER

                   MIXED WITH BASES

         LUBRICANTS APPLY IN MOLDS

    PLACED THE MASSES IN CYLINDER

                     APPLY PRESSURE

              RELEASE SUPPOSITORY

COOLED    PACKED    STORED
                               Page 47
 ADVANTAGE-

 It is suitable for thermolabile drugs
  because in this method no heat is
  required.

 Rate of production is more.

 DISADVANTAGE-

 The main disadvantage is air
  entrapment occurs during production
  so oxidation takes place in suppository.


                                     Page 48
(4) HEAT MOLDING
 In this process the bases are melted and
  the drugs , additives are mixed in bases.

 The following methods are involved in
  this process-

(a)Melting the bases
(b)Incorporation of the drugs and other
   additives
(c)Filling of mold
(d)Cooling and collection of suppositories


                                    Page 49
 Incorporation of drug and additives-

 the drugs and additives are in solid form ,
  they are converted in fine powder and
  mixed properly on a warm tile.



 Triturate the ingredient on warm tile with
  the sufficient water.



 These above liquid are mixed in melted
  bases in half amount after mixing , then
  added remaining liquid in bases.

                                    Page 50
 FILLING OF MOLDS-

 First the lubricants are apply in molds.

 Then the above masses are introducing
  in molds.

 During introducing the masses in
  molds the stirring should be done to
  prevent the sedimentation of insoluble
  solids , if they present.

 Overfilling is required to prevent the
  depression in suppositories.

                                     Page 51
 COOLING AND COLLECTION OF
        SUPPOSITORIES

 After the2-3 min . the mass just sets.
  Then remove the excess mass with warm
  spatula.

 Cool the suppositories for 10-15 min. in
  refrigerators.

 Then open the mold and collect the
  suppositories and packed.



                                    Page 52
MELTING THE BASES       DRUGS

                        FINE
 POWDER

                          TRITURATE
                    WITH WARM WATER

                        LIQUIDS

           MIXED ½ PARTS OF
 LIQUIDS

                    MIXING PROPER
                               Page 53
CONT……

  APPLY THE LUBRICANTS IN MOLD

  OVERFILLING OF MASSESIN MOLDS

    REMOVE THE EXTRA MASSES

         COOLING (10-15MIN)

           OPEN MOLDS

             PACKED

                              Page 54
              STORED
PACKING OF SUPPOSITORIES

 (1) DISPOSABLE MOLDS-
  These are meant for packing the
       suppositories.
 These are made of plastics or aluminium
           foil.




                                 Page 55
(2) MODERN PACKING MACHINE

 It is consist of roll of packing material
which cut in the required size and rolled
        around each suppositories.




                                     Page 56
• STORAGE CONDITION

 It is stored at 10-15 0c



 Used air tight container



 The suppositories with cocoa butter
  stored at < 30 0c.



 The suppositories with glycero-gelatin
  stored at < 35 0c.
                                   Page 57
EVALUATION OF SUPPOSITORIES

  Test of appearance(size , shape)

  Test of physical strength

  Test of dissolution rate

  Test of melting range

  Test of softening time

  Test of uniformity of drug content
                                      Page 58
STABILITY PROBLEMS OF
   SUPPOSITORIES
 BLOOMING-
 During storage , cocoa butter
  suppositories sometimes show
  deposition of white powder on the
  surface.
 This result in suppositories of
  disagreeable appearance.
 HARDENING-
 During storage , the suppositories made
  of fatty bases become hard.
 I is occurs due to crystallization of bases.
 This also effect the melting and rate of
  absorption of drugs.                 Page 59
THANKS

     Page 60
Page 61

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Suppository

  • 1. SEMI SOLID PREPARATION SUPPOSITORY PRESENTED BY MANOJ KUMAR M.PHARM (AMITY UNIVERSITY) Page 1
  • 2. SUPPOSITORY  It is solid dosage form meant to be inserted into Body cavity like rectum , urethra, vagina, where they melt or soften to release the drugs and produce their local or systemic effect.  It is comes under semi solid preparation because it is prepared by melting all ingredients (bases and other additives along with active ingredient).  All types of suppositories are melt at normal body temperature after introducing in body cavity and produce their effect. Page 2
  • 3. ADVANTANGE OF SUPPOSITORY  It is the alternated dosage form for drugs which have less bioavailability when it is taken orally.  Drugs having bad odour and taste can be used in suppository form.  It is suitable for unconscious patients which can not taken drugs orally.  It is suitable for drugs which produce irritating effect in GIT.  It is suitable for infants and old people who find difficulty in swallowing of drugs.  It is suitable for the drugs which are destroyed by portal circulation. Page 3
  • 4. DISADVANTAGE OF SUPPOSITORY  The manufacturing process is more difficult as compare other formulation.  The drugs which cause irritation to mucous membrane can not be administrated by this form.  The most important problem is storage condition because it stored at low temp. (10-20 0c ). Other than the bases get liquefied.  Leakage problem is also most critical problem along with suppository after introducing in body cavity at elevated temperature. Page 4
  • 5. TYPES OF SUPPOSITORY (A)RECTAL SUPPOSITORY-  It is inserted in the rectal .  The weight of suppository used in children is about 1g and in adult about 2g.  The shape of suppository used in rectal is torpedo shape. The length is about 3 Page 5 cm.
  • 6. (B) URETHRAL SUPPOSITORY  The weight of this type suppository is about 2g and 60-75 mm long in Females.  Those intended for males weigh 4 gm each and are 100-150 mm long.  It is available in pencil shape. Page 6
  • 7. (C) VAGINAL SUPPOSITORY  It is in oviform shape.  It is about 3-5g in weight.  It is contains the drugs which are used in treatment of the infections of female genitourinary tract and meant for contraception.  It is contains the combination of polyethylene glycol of different molecular weights as suppository bases. Page 7
  • 8. (D) NASAL SUPPOSITORY  These suppository are meant for introduction into nasal cavity.  It is about 1g in weight.  The glycero- gelatin is used as suppository bases. (E) EAR CONE  It is also known as AURINARIES.  These are meant for introduction into the ear.  It is cylindrical in shape.  It is about 1g in weight. Page 8
  • 9. VARIOUS SHAPES OF SUPPOSITORY Page 9
  • 10. FORMULATION OF SUPPOSITORIES (A) SUPPOSITORIES BASES- IDEAL PROPERTIES OF SUPPOSITRIES BASES- The following properties should be required for bases---  Bases should be exist in solid form at room temperature.  It should not irritate and produced inflamed sensation in body cavity.  It should be stable during storage condition , No change in colour, shape , odour. Page 10  It should retain hardness and
  • 11. IDEAL PROPERTIES OF SUPPOSITRY BASES  It should not reacts with drugs and additives.  It should have good emulsifying and wetting property.  It should have acid value less than 0.2 or zero.  It should have iodine value less than 7.  It should have sponification no. range between200-245. Page 11
  • 12. (1) HYDROPHILIC BASES (A) WATER DISPERSIBLE BASES-  These are the mixture of non ionic surfactants which are chemically related to polyethylene glycol.  These are used alone or in combination with other type of bases.  Cellulose derivatives like methylcellulose, sod.carboxymethyl cellulose are also comes under this class. Page 12
  • 13. Advantages  They are suitable for both water soluble and oil soluble drugs.  They do not support the growth of microbes in the preparation.  They can be stored at elevated temperature. Disadvantages-  This types of bases are interact with few drugs and alter the bioavailability of these drugs. Page 13
  • 14. EXAMPLES  Polyoxyethylene sorbitan fatty acid ester(TWEENS)  Polyoxyethelene stearates(MYRIS)  Sorbitan fatty acid esters(SPANS)  Combination of Tween 61(60%) and Tween 60(40%)  Combination of Tween 61 (85%) and glyceryl monostearate (15%) Page 14
  • 15. (B) WATER SOLUBLE BASES (1) GLYCERO-GELATIN-  This occurs as a gels  It is a mixture of gelatin, glycerol, and water.  According to BP the composition of the bases – GELATIN- 14% w/w GLYCEROL– 70% w/w WATER– QS  For gets a stiff mass , the quantity of gelatin should be increased to 32.5% and reduced the glycerol to 40%. Page 15
  • 16. PREPARATION OF GLYCERO-GELATINE BASES GLYCEROL WATER GELATINE GLYCERO-GELATINE BASES Page 16
  • 17. ADVANTAGES  Suppository prepared by glycero-gelatin bases are strong and translucent unlike cocoa butter suppositories.  This base is disperse slowly in the body cavity fluids and provides prolonged release and action of drugs. DISADVANTAGES-  It absorbs moisture and promotes microbial growth , so this reason preservatives are used . Page 17
  • 18. DISADVANTAGES  The bases are show incompatibility with protiens prescipitants due to the gelatin  It causes dehydration and irritation of rectal mucosa  It exerts undesirable laxative action.  It requires special storage condition at about 10-15 0c.  Handling and manufacturing of these type of suppository are difficult. Page 18
  • 19. (2) POLY ETHYLENE GLYCOL(POLYGLYCOL)  It is also called as PASTONALS (GERMANY).  CARBOWAXES(U.S)  They are long chain polymers of ethylene oxide.  They occur in liquid and solids.  Liquids have mol.weight about 200-600.  Solid have mol.weight about more than 1000.  They are also called as macrogols.  They are the mixture of two or more grades of macrogols used as suppository bases. Page 19
  • 20. EXAMPLES  PEG 4000- 33 parts PEG 6000- 47 parts PURIFIED WATER- 20 parts  FOR HARD SUPPOSITORY PEG 1000- 75 parts PEG 4000- 25 parts  FOR SOFT SUPPOSITORY PEG 1000- 96 parts PEG 4000- 4 parts Page 20
  • 21. ADVANTAGES  This base is thermostable.  It does not get degraded or hydrolysed.  It does not support microbial growth.  It dose not move out from body cavity after introducing.  It has good water absorbing capacity.  It is chemically stable. Page 21
  • 22. DISADVANTAGES  It is susceptible to rancidification,so it should be stored in dry place away from light.  It melt easily in warm weather,so it should stored in cool place in warm season.  Large quantities of water can not be incorporated into the bases.So emulsifier such as tween 61 (6-10%) are useful to increase the absorption of water.  The physical characteristics of the bases are change from batch to batch.  Some times leakage may be occur after introducing in body cavity. Page 22
  • 23. (2) LIPOPHILIC BASES (a) COCOA BUTTER  It is natural triglyceride.  Among all fatty acid about 40% are unsaturated fatty acid .  It can exist in more than one crystalline form or exhibits polymorphism.  At room temperature ,it is yellowish- white with a paints,chocolate like odour.  It consists of a mixture of ester of oleic acid,palmatic acid,stearic acid and other fatty acid with glycerol. Page 23
  • 24. ADVANTAGES  It is liquified readily on warming and sets rapidly on cooling.  It has emollient effect which is useful to relieve inflammation.  It shows good release of water soluble drugs.  It does not cause irritation in mucous membrane. Page 24
  • 25. DISADVANTAGES  It is susceptible to rancidification ,so it should be stored in dry place away from light.  It gives soft suppository when formulated along with chloral hydrate , phenol, volatile oil, which have lower melting point.  The physical property of the base is vary from batch to batch.  It required extra lubricant during poring in holder.  Some times leakage may be occur. Page 25
  • 26. (B) ANTI OXIDANTS  It is protect the drugs and bases from getting degraded due to oxidation.  These are commonly used in all types of suppositories. EXAMPLES-  Ethyl or propyl gallate  Ascorbic acid  Butylated hydroxy anisole (BHA)  Butylated hydroxy toluene (BHT)  Hydroquinone  Tocopherol Page 26
  • 27. (C) EMULSIFYING AGENTS  These are increase the water absorbing capacity of fatty bases.  EXAMPLES  Poly sorbates (TWEEN 61)  Wool alcohol  Wool fats Page 27
  • 28. (D) HARDENING AGENTS  These are involved in those formulation where the melting point of the bases is decrease by the drugs.  These are the agents which are used to bring the melting point to normal.  EXAMPLES  Beeswax  Macrogols at high molecular weight. Page 28
  • 29. (E) PRESERVATIVES  These are the agents which are used in prevent the growth of microbial in suppository which contains water soluble bases.  EXAMPLES  Chorocresol  Methyl paraben  Propyl paraben Page 29
  • 30. (F) THICKENING AGENTS  These are the agents which are used to increases the viscosity of molten bases and prevent sedimentation of suspended in solid bases.  EXAMPLES  Aluminium monostearate  Colloidal silica  Magnisium stearate  Steary alcohol Page 30
  • 31. (G) PLASTICIZERS  These are the agent which are used to improved flexibility of suppositories.  It is also used to make the less brittles to suppositories.  EXAMPLES  Castor oils  Glycerine  Glycol  Tween 80  Tween 85 Page 31
  • 32. METHODS OF PREPARATION OF SUPPOSITORIES MOLDS USED IN PREPARATION OF SUPPOSITORIES-  Molds used in preparation of suppositories are the metals devised with different shape.  It is consists of two or more parts which are joined with a screw.  In side the molds the cavities are made up of aluminium , brass, stainless steel , plastics.  Molds have different capacities like 1,2,4,8gm. Page 32
  • 33. Mold Page 33
  • 34. PLASTICS MOLDS Page 34
  • 35. CALIBRATION OF THE MOLDSCC  The first step is to prepare molded suppositories from base material alone.  The suppository's combined and average weight is recorded.  To determine the volume of the mold, the suppositories are melted in a calibrated beaker, and the volume of the melt is determined. Page 35
  • 36. LUBRICANTS USED IN MOLDS  Cocoa butter and glycero-gelatine bases are required lubrication of molds.  This is prevent sticking of bases to the wall of molds cavity.  It is also useful in easy removal of suppositories from the molds.  The lubricants are form a film between the wall of mold cavity and base of suppositories so it prevent adhering of bases to the molds.  The nature of lubricants should be different from nature of bases. Page 36
  • 37. EXAMPLES (1) FOR COCOA BUTTER BASES ALCOHOL(90%)- 50ml GLYCEROL - 10ml SOFT SOAP - 10 gm (2) LIQUID PARAFFIN (3) ARACHIS OILS Page 37
  • 38. MANUFACTURING OF SUPPOSITORIES  Hand molding  Automatics Machine Molding  Compression Molding  Heat Molding 1) HAND MOLDING-  Hand molding is useful when we are preparing a small number of suppositories.  It is suitable for thermo labile drugs.  It is more economical methods.  It is more time consuming and not uniformity process. Page 38
  • 39. STEPS INVOLVED IN HAND MOLDING  The drugs and other additives are made into a fine powder .  It is incorporated into the suppository base by kneading with it or by trituration in a mortar.  Then these masses are rolled into the shape of a cylindrical rod on the rolling tile in presence of lubricants to prevent the adherence of masses.  Then cut the rods and made one end to Page 39 pointed.
  • 40. DRUG+ADDITIVES FINE POWDER MIXED IN BASES APPLY LUBRICANTS ON ROLLING TILE ABOVE MASSES ARE ROOLED IN CYLINDRICAL SHAPE CUT THE RODS PACKED STORED 40 Page
  • 41. (2) AUTOMATIC MACHINE MOLDING  All the operations in pour molding are done by automatic machines.  Using this machine, up to about 10,000 suppositories per hour can be produced.  By this the rate of production of suppositories is more higher than hand molding.  In this ,there are no chance of air entrapment and contamination of suppositories.  In this ,if any mass deposited in mold is not removed during cleaning, so produce overweight suppositories with mold marks. Page 41
  • 42. There are two types of machines used they are following--- (a)Rotary Machine-  The rate of production of suppositories are about 3500-6000/hr.  This machine consists of a turn table in which metal molds are fitted.  This table rotates sequentially, the mold gets filled with drug , additives, bases and cooled and ejects the suppositories.  Before mass filled in mold ,the lubricant are apply in mold wall.  The excess mass is removed by the scraping unit.  The cooling system results the solidification of suppositories. Page 42
  • 43.  After the cooling the mold is moves towards ejection station , it consists of a stainless steel rod which push out the suppositories from molds.  Then completed the ejection process , the empty molds are again moves towards the filling unit for further processes.  STEPS INVOLVED IN PROCESS AS FOLLOWING Page 43
  • 44. DRUG+ADDITIVES FINE POWDER MELT BASES + POWER HOPPER LUBRICATED THE MOLDS FILL ABOVE MIXTURE IN MOLD COOLING SYSTEM EJECTION SYSTEM PACKED STORED Page 44
  • 45. (b) LINEAR MACHINE  It is similar to rotary machine.  Except the rate of production is more higher than rotary machine about 10000/hr.  All steps involved is similar to rotary machine.  There is no chance of air entrapment and contamination of suppositories as similar to rotary machine.  The rate of production is higher than rotary machine. Page 45
  • 46. (3) COMPRESSION MOLDING  CONSTRUCTION- The compression machine consists of a cylinder, piston , molds, and a metallic stop plate at the bottom.  WORKING- When placed the mass in cylinder and apply the pressure .  Then mass fulfill in mold move and s remove the suppositories and keep them in cool placed.  After cooling release them from compression machine and packed . Page 46
  • 47. PROCEDURE DRUG+ADDITIVES FINE POWDER MIXED WITH BASES LUBRICANTS APPLY IN MOLDS PLACED THE MASSES IN CYLINDER APPLY PRESSURE RELEASE SUPPOSITORY COOLED PACKED STORED Page 47
  • 48.  ADVANTAGE-  It is suitable for thermolabile drugs because in this method no heat is required.  Rate of production is more.  DISADVANTAGE-  The main disadvantage is air entrapment occurs during production so oxidation takes place in suppository. Page 48
  • 49. (4) HEAT MOLDING  In this process the bases are melted and the drugs , additives are mixed in bases.  The following methods are involved in this process- (a)Melting the bases (b)Incorporation of the drugs and other additives (c)Filling of mold (d)Cooling and collection of suppositories Page 49
  • 50.  Incorporation of drug and additives-  the drugs and additives are in solid form , they are converted in fine powder and mixed properly on a warm tile.  Triturate the ingredient on warm tile with the sufficient water.  These above liquid are mixed in melted bases in half amount after mixing , then added remaining liquid in bases. Page 50
  • 51.  FILLING OF MOLDS-  First the lubricants are apply in molds.  Then the above masses are introducing in molds.  During introducing the masses in molds the stirring should be done to prevent the sedimentation of insoluble solids , if they present.  Overfilling is required to prevent the depression in suppositories. Page 51
  • 52.  COOLING AND COLLECTION OF SUPPOSITORIES  After the2-3 min . the mass just sets. Then remove the excess mass with warm spatula.  Cool the suppositories for 10-15 min. in refrigerators.  Then open the mold and collect the suppositories and packed. Page 52
  • 53. MELTING THE BASES DRUGS FINE POWDER TRITURATE WITH WARM WATER LIQUIDS MIXED ½ PARTS OF LIQUIDS MIXING PROPER Page 53
  • 54. CONT…… APPLY THE LUBRICANTS IN MOLD OVERFILLING OF MASSESIN MOLDS REMOVE THE EXTRA MASSES COOLING (10-15MIN) OPEN MOLDS PACKED Page 54 STORED
  • 55. PACKING OF SUPPOSITORIES (1) DISPOSABLE MOLDS- These are meant for packing the suppositories. These are made of plastics or aluminium foil. Page 55
  • 56. (2) MODERN PACKING MACHINE It is consist of roll of packing material which cut in the required size and rolled around each suppositories. Page 56
  • 57. • STORAGE CONDITION  It is stored at 10-15 0c  Used air tight container  The suppositories with cocoa butter stored at < 30 0c.  The suppositories with glycero-gelatin stored at < 35 0c. Page 57
  • 58. EVALUATION OF SUPPOSITORIES  Test of appearance(size , shape)  Test of physical strength  Test of dissolution rate  Test of melting range  Test of softening time  Test of uniformity of drug content Page 58
  • 59. STABILITY PROBLEMS OF SUPPOSITORIES  BLOOMING-  During storage , cocoa butter suppositories sometimes show deposition of white powder on the surface.  This result in suppositories of disagreeable appearance.  HARDENING-  During storage , the suppositories made of fatty bases become hard.  I is occurs due to crystallization of bases.  This also effect the melting and rate of absorption of drugs. Page 59
  • 60. THANKS Page 60