DESICCANTS ARE HYGROSCOPIC SUBSTANCE THAT REMOVE MOISTURE FROM ITS SURROUNDING. ENVIRNMENT,OR SAY IT ATTRACT & RETAIN WATER VAPOR TOWARDS ITSELF. Syn; HYGROSCOPY,DELIQUESCENCE,HUMECTANT WORKING PRINCIPLE OF DESICCANT. SILICA GEL INDICATING SILICA GELS MOLECULAR SIEVES DESICCANT CLAY (MONTMORILLONITE CLAY) CALCIUM OXIDE Pharmaceutical coil is substance that ensures freshness and stability to the product during shipping and storing. COTTON,RAYON and POLYESTER

1. DESICCANT FOR PHARMACEUTICAL
APPLICATION &
PHARMACEUTICAL
COIL
COTTON/
RAYON/
POLYESTER
DESICCANT
INSERT
Saurav Anand
IIP, MBA

2. DESICCANT
DESICCANTS ARE HYGROSCOPIC SUBSTANCE
THAT REMOVE MOISTURE FROM ITS SURROUNDING.
ENVIRNMENT,OR SAY IT ATTRACT & RETAIN WATER
VAPOR TOWARDS ITSELF.
Syn; HYGROSCOPY,DELIQUESCENCE,HUMECTANT
WORKING PRINCIPLE OF DESICCANT.
ABSORBENT TYPE
WATER ABSORB INTO
THE DESICCANT.
 LARGE ABSORBING
CAPACITY.
 NOT RE-USED.
Ex-- CaO.
ADSORBENT TYPE
WATER ADSORB ONTO
(SURFACE AREA) THE
DESICCANT.
 SMALLER ADSORBING
CAPACITY.
 RE-USED.
Ex-- SILICA GEL.

3. ADSORPTION PHENOMENA

4. COMMON PRINCIPLE
DESICCANT REMOVE WATER FROM THE AIR
SPACE BY:
 SINGLE LAEYR & MULTI-LAYER ADSORBPTION:
IT DEPENDS ON FORCE OF ATTRACTION
(BETWEEN ADSORBENT AND ADSORBATE)
PORE SIZE OF DESICCANT
 VAPOR PRESSUR DIFFERENCE BETWEEN
ADSORBENT SURFACE AND ENVIRONMENT
 CAPILLARY CONDENSATION---THE SMALLER
PORES BECOME FILLED WITH WATER

5. REASON FOR DESICCANT USE
 PROTECT FROM CORROSION, MOLD
MILDEW GROW.
 PREVENT FROM TABLET STICKNESS.
 PREVENT FROM HYDROLYSIS OF DRUG.
 TO PREVENT NEW DRUG AND
EFFERVECENT TABLET DURING
PACKAGING.

6. LIST OF COMMON DESICCANT
SILICA GEL
INDICATING SILICA GELS
MOLECULAR SIEVES
DESICCANT CLAY
(MONTMORILLONITE CLAY)
CALCIUM OXIDE

7. SILICA GEL (SiO2)
 Amorphous micro-porous structure.
 High Surface Area (around 800 m²/g)
 Pore opening sizes 3-60 A.۫
 Best Performance At
RT (70° to 90°F).
HIGH RH (60 to 90% RH).
 Non-Corrosive, Nontoxic Nature
 US FDA Approved for use in Food
& Drug packaging.

8. MOL. STRUCTURE
 Regenerated temp-120 C
 Adsorb up to one third of its own weight

9. INDICATING SILICA GEL(ISG)
 Visual color change
 Contain- Cobalt chloride
(Colour Developer)
 (CoCl2) (CoCl2•2H2O)
H2O [Co(H2O)6]Cl2
 The color changes as the
desiccant goes past 8%
moisture levels (by wt)
Indicates it is time to
replace the desiccant
DRY
ISG
WET
ISG
NORMAL
SILICA

10. MOLECULAR SIEVE
(SYNTHETIC ZEOLITE)
 FORMULA-Myx/y[AlxSi1–xO2].
Ex---Na20.A1203.(Si02)x.(H20)y.
 Crystalline Structure with uniform pore size
 Adsorptive surface area 700 to 800 sq. m per g
 Adsorb moisture at low as well as high RH.
 3A (pore size 3 Å): Adsorbs NH3, H2O,
 4A (pore size 4 Å): Adsorbs H2O, CO2, SO2, H2S,
C2H4, C2H6, C3H6, EtOH

11. CONTD….
 Muddy powder like
 Higher in cost per unit, but extremely large
range of adsorptive capabilities.
 Manufactured
Gelling process.
Clay process.

12. MONTMORILLONITE CLAY
 Naturally occurring
 Porous adsorbent
 Main component is the layered mineral Ca-montmorillonite,
Ca0.16[Al1.68Mg0.32(OH)2(Si4O10)]
 Adsorbent property is created by the controlled
drying naturally occurring Clay
 Clay reacts relatively
slowly at low as well as high
humidity levels

13. CONTD….
 Best performance at below 120°F
(approximately 50°C), above 120°F,
possibility that the clay will give-up
moisture (Storage Condition should
mention )
 Work good at LOW as well
HIGH RH condition
 Least expensive desiccant
per pound

14. CALCIUM OXIDE(CaO)
 ABSORPTION PROCESS
 ACT SLOWLY, It take a days to
reach its maximum capacity
 CaO(s) + H2O(l) Ca(OH)2(s) + (heat)
 Absorbs moisture, it SWELLS. Proper desiccant
packaging is required for effective use Limited
to primarily the packaging of dehydrated FOODS
 Absorb a much greater amount of water at low
relative humidity
 Retain moisture at high temp
 Relatively inexpensive

15. COMPARISON SHEET OF DESICCANT
Property Molecular
Sieve
Silica
Gel
Montmo
rillonite
Clay
CaO CaSO4
Adsorptive Capacity
at low H20 Conc.
Excellent Poor Fair Excell
ent
Good
Rate of Adsorption Excellent Good Good Poor Good
Capacity for Water
High High Medium High Low
@77° F, 40% RH
Separation by
Molecular Sizes
Yes No No No No
Adsorptive Capacity
at Elevated Temp.
Excellent Poor Poor Good Good

16. COMPARISON GRAPH OF DESICCANT

17. EQUILIBRIUM H2O CAPACITY

18. AMOUNT OF DESICCANT
 Volume of air space to be desiccated
 Nature of the material to be protected
 Moisture surrounding to the package
 Type of desiccant to be used
 Length of time for protection
 Atmospheric conditions (Temp & RH)
when/where the product is packed, sealed,
shipment and storage

19. WATER CONTAMINATION IN A
CLOSED CONTAINER
 The water vapor in the air inside the package
 The water vapor adsorbed by the materials
inside the package
 The water vapor on the walls of the package
 The permeation of water vapor into the
package

20. Choosing the Right Solution for
Desiccant
Two main parameter
Adsorption Capacity
Adsorption Rate
weight, size, and shape restrictions of the
package; dust requirements; process
restrictions; and cost
 Adsorption Capacity
Mtotal = Minitial + Minflow
(Mheadspace + Mrm) + Minflow

21. THE AMOUNT OF DESICCANT….
 Mtotal / The adsorption capacity of the desiccant at the
maximum allowable relative humidity.
 Ex Mtotal = 0.1 g
The maximum allowable relative humidity is 20%,
the adsorption capacity of desiccant clay is 13%.
Amount of clay needed is 0.78g (0.1 / 0.13)
Under these same conditions.
silica gel = 0.87g
molecular sieve = 0.55g
 We Take nearest standard desiccant product size. For
the above example, 1 g of clay, 1 g of silica gel, or
0.75 g of molecular sieve would suffice

22. THE AMOUNT OF DESICCANT….
 Adsorption Rate
Time taken to reduce the relative humidity
in a closed container from 20% to virtually
0%
Molecular sieve--within 5 minutes
Desiccant clay -- within 20 minutes
Silica gel-- About 60 minutes
 In most cases, the kinetics for desorption of
water from the product are slower than the
adsorption kinetics of the desiccant

23. THE AMOUNT OF DESICCANT….
 In packaging line Moisture uptake during
this exposure time reduces the desiccant's
adsorption capacity
 For example:
1) Small molecular sieve packets are
extremely difficult to handle and require
humidity control during dispensing
2) Desiccant canisters, inserts, and stoppers
react more slowly than packets or tablets

24. UNIT OF DESICCANT
IN 1973,THE DOD (In USA) FOLLOWED WITH
SPECIFICATIONS FOR DESICCANT IN
PACKAGING OF ITEMS
•MIL-D-3464 and MIL-P-116.(USA Army)
•DIN 55473 and 55474(In Europe)
•TL 6850 - 008 (German Army)
3 grams at 20% Relative Humidity
6 grams at 40% Relative Humidity
A "Unit" At 77°F (25°C)
Clay = 33g.
Silica gel = 28g
Molecular sieve = 28g

25. DESICCANT PRODUCTS
 CANISTERS--sizes =13.9x17.8mm,13.9x25.7mm,and 19.4 x
15.8 mm. diameter.
Weight of desiccant fill-- 0.25g and 27g
High-speed product insertion.
less potential for contamination and machine jamming
 PACKETS--Weight of desiccant fill- 0.25 g and 10 g
Face stock materials--
DTII (polyester and polyolefin non woven)
Tyvek (spun bonded polyolefin)
 TABLETS & CAPSULE--Any size and shape
Accommodate high-speed production
Capsule with silica gel used
Freeze drier, 000 Size

26. CONT….
 CAP INSERTS-- Fit into screw-on caps
No extra space
No equipment is needed to insert
 TUBE AND STOPPER SYSTEM-- Most advanced
moisture-protection
Child resistance. tamper evidence
Tight-fitting, vacuum-sealed package.
APPLICATION—Diagnostic and pharmaceutical
Protect from moisture damage as well as crushing
 DESICCANT-FILLED POLYMERS—
Outer layer--moisture-impermeable material
Inner layer-- desiccant-filled polymer material
ALCAN-(oPA/Adhesive/Primer/Alu/Tie layer/PE+Desiccant/PE)

27. CONT….
 HOT-MELT DESICCANTS--
Use in any-volume containers
Using hot-melt equipment and applied
directly to packaging materials.
The non dusting, non toxic USED IN-- sealed pouches,
bottles, and blister packs
 DESICCANT TAPE--Supplied in either rolls or precut
strips
Available in either silica-gel or molecular-sieve.
Adapt easily to existing labeling equipment.

28. NEW TECHNOLOGIES DESICCANT
 NEW AIDS and CANCER DRUG
High moisture and oxygen Sensitive
“Technology That protects a product from
oxidation, and it works really well at low relative
humidities,”
 packaging for effervescence tablets and for
pharmaceutical powders,”

29. CONT…
 Desiccant polymer tubes The tubes have
desiccant protection injection molded into the
polymer itself.
 Desiccant Lined Vials One piece
desiccant lined vials for use with
moisture sensitive blood glucose
diagnostic strips, medical devices
or effervescent vitamin tablets.

30. CONT.
Desiccant Plastics: DESICCANT ACTIVE POUCH

31. CONT

32. TYPE
COTTON REYON POLYESTER

33. PHARMACEUTICAL COILS
 Pharmaceutical coil is substance that
ensures freshness and stability to
the product during shipping and
storing.
 Pharmaceutical coil provide
Cushioning.
Safe for Tablets.
Absorb dust.
Economical aesthetically pleasing.

34. COTTON
FEATUERES
Natural fiber.
Cuts easily.
Moisture content is NMT 8.0%.
Creates a dry environment
inside the bottle.
Biodegradable.
Used in bottling of tablets and
capsules

35. RAYON
FEATURES
 Man-made fiber (cellulose).
 Uniform fiber length.
 Cuts or tears easily.(Dull Knife)
 Moisture content is NMT 11%.
 Biodegradable.
 Most commonly used in the bottling
of tablets and capsules.

36. POLYESTER
FEATURES
Man-made fiber (petroleum derived).
Uniform in fiber length.
Non-fluorescent.
Non-absorbent – will not introduce
moisture or extract.
Moisture content is NMT 1%.
Used in bottling of soft-gel capsules.

37. PHARMACEUTICAL COIL
FACTS
 Gram weight - the weight of the coil
per one yard length.
 Standard industry gram weights
9 grams
12 grams
16 grams
 Cotton and rayon coil meets USP and
EP standards

38. REGULATORY REQUIRMENTS
 USP.
 IP.
 EP.
 Excess residual peroxide has been observed to
produce stability problems in tablets.
 Furfural and other aldehydes can cause
gelatin crosslinking.
 The polyester threads are usually coated with a
solutioncontaining lubricants, emulsifiers,and
antistatic agents. Polyester should comply with
applicable sections of 21 CFR.