packging of semisolids

2. SEMISOLID DOSAGE FORM
• OINTMENT
• PASTE
• GEL

3. PRESENT BY
• DR QURESHI JALIB

4. OINTMENTS
• Ointments are semisolid preparations
intended for external application to the skin or
mucous membrane .
• May be medicated or not.

5. Ointment bases
• Ointment bases are classified into four groups
• Oleaginous bases
• Absorption bases
• Water removable bases
• Water soluble Bases

6. • OLEAGINOUS BASES
• They are termed as hydrocarbon bases .
• On application to the skin they have an emollient
effect, protect against escape of moisture.
• Remain on skin for long period without drying
out.
• Difficult to wash.
• E.g. Petrolatum , white petrolatum, white
ointment.

7. • ABSORPTION BASES
• Are of two types.
Those that permit incorporation of aqueous
solutions resulting in formation of W/O
emulsions.
• E.g. Hydrophilic petrolatum

8. Those that are W/O emulsion that permit the
incorporation of additional quantities of aqueous
solutions.
• E.g.. Lanolin
• Used as,
• Emollients.
• Adjutants.
They are not easily removed from the skin with
water washing.

9. • WATER REMOVABLE BASES.
• Are O/W emulsion resembling creams.
• Easily washed from skin often called water
washable bases.
• May be diluted with water.
• E.g.. Hydrophilic ointment.

10. • WATER SOLUBLE BASES
• Do not contain oleaginous component
• completely water washable and often referred
as grease less.
• E.g. polyethylene glycol ointment

16. • STABILITY OF OINTMENTS
• The ointments should remain stable from the time of preparation to the
time when the whole of it is consumed by the user.
• (i) To stop microbial growth preservatives are added. Preservatives for
ointment includes : p-hydroxy benzoates, phenol, benzoic acid, sorbic
acid, methyl paraben, propyl paraben, quaternary ammonium
compounds, mercury compounds etc.
• (ii) The preservatives should not react with any of the component of the
formulation. Plastic containers may absorb the preservative and thereby
decreasing the concentration of preservative available for killing the
bacteria.
• (iii) Some ingredients like wool fat and wool alcohols are susceptible to
oxidation. Therefore, a suitable antioxidant may be incorporated to
protect the active ingredients from oxidation.
• (iv) Incompatible drugs, emulsifying agents and preservatives must be
avoided. The drugs which are likely to hydrolyze must be dispensed in an
anhydrous base.
• (v) Humectants such as, glycerin, propylene glycol and sorbitol may be
added to prevent the loss of moisture from the preparation.
• (vi) Ointment must be stored at an optimum temperature otherwise
separation of phases may take place in the emulsified products which
may be very difficult to remix to get a uniform product.

24. EQUIPMENTS
AGITATOR MIXERS
PLANETARY MIXERS
SIGMA MIXERS
PROPELLER MIXERS
SHEAR MIXERS
TRIPLE ROLLER MILL
COLLOIDAL MILL

25. PLANETARY MIXERS
Mixing , blending and low-shear granulation.
Two blades, rotate on their own axis.
Blades advance to periphery of vessel.
Ideal for mixing and kneading of viscous paste.
Jacket
Capacity : 5liters-500liters.

26. ADVANTAGES
 EASE OF CLEANING
 EASE OF DISCHARGE
 ENERGY SAVING

28. SIGMA MIXERS
• Called so because blade resembles Greek
letter sigma.
• Two blades
• Heavy construction and high power of mixing.
• Jacket

29. • Handle 100-200kg material.
• 7-10 horse power, greater kneading and
massing action
• DIFFICULTY
• Entrapment of air.
• SOLUTION
• Under reduced pressure.

31. PROPELLER MIXER
• Electrically operated propeller type mixer
• Manually adjusted and positioned in mixing
vessel to achieve maximum turbulence.
• Angle of shaft and depth of propeller can be
varied.
• Metal spatula can be held as baffle.
• Rotates upto 8,000rpm

34. TRIPLE ROLLER MILL
• Fitted with three rollers.
• Close contact and rotate at different speed.
• Size depends on gap and speed.
• Hopper
• Scrapper

37. COLLOID MILL
• Principle: shearing
• Conical rotor and stator.
• Gap: 0.005-0.075cms.
• Rotor connected to high speed motor (3,000-
20,000 rpm).

40. PACKAGING OF SEMISOLIDS
Topical dermatological products are packaged in
either jars , tubes or syringes.
Ophthalmic nasal and rectal semisolid products
are always packaged in tubes or syringes.

41. • Jars and tubes are first tested for compatibility
and stability of intended product.
• This includes stability testing at room temp.
(20°C) as well as under accelerated stability
testing conditions.(40°C and 50 °C).

42. • Ointments jars are made up of clear or
opaque glass or plastic.
• Some are colored green, amber or blue.
• Vary in size from about o.5oz to 1lb.
• Opaque jars use for light sensitive products
are porcelain white, dark green or amber.

43. Ointment tubes are:
• light in weight
• Inexpensive
• Convenient for use
• Compatible with most formulation
• Provide greater protection against
contamination and environmental conditions
than jars.

44. • Ointment tubes are made up of aluminum or plastic .
• Tubes of aluminum are coated with an epoxy resin,
vinyl .
• Plastic tubes are made of HDPE OR LDPE OR PP OR PET.
• Multiple dose tubes have conventional continuous
thread closures.
• Single dose tube are prepare with tear away tip.
• Metered-dose ,temper evident and child resistant
closures are also available.
• Standard sizes of empty tubes have capacity of
1.5,2,3.5, 5,15,30,45,60 and 120 gram.

45. FILLING OF OINTMENT JARS
• On small scale ointment jar ,are filled by carefully
transferring the weighed amount of ointment
into the jar with spatula.
• Ointment is packed in such a way avoiding the
entrapment of air.
• Ointments prepared by fusion may be poured
directly into the jar.
• Large scale
• Pressure fillers force the specified amount in the
jars.

46. FILLING OF OINTMENT TUBES
• Tubes are filled from the open back end of the
tube opposite from the cap end .
• Ointments prepared by fusion may be poured
while still soft but viscous directly into the
tube.
• On small scale, tube may be filled manually or
with a small scale filling machine.
• Filled tube is closed and sealed.

47. Manual filling:
• It requires following steps:
• Placed on waxed paper, rolled (cylindrical
shape), inserted and pushed forward.
• Pressing against lower portion of tube.
• Making crease below ointment fill, removing
paper and leaving ointment in tube.
• Bottom is flattened, folded and sealed.

48. Steps of manual filling of tube

49. Manual filling machine

50. • Automatic filling
• Different kind of machines are used for
automatic filling.
• Depending on model have
• different capacities to fill
• 1,000-6,000 tubes per hour.

51. Small scale fully automatic
filling and crimping
machine for collapsible tubes.
Capacity : 60 units per minute.

52. Arenco tube filling machine.
Automatically fills 125 tubes a minute.

54. FILLING OF SYRINGES
Syringes are filled either:
• Drawing into barrel using plunger.
• Removing plunger and filling through back.