DESICCANT FOR PHARMACEUTICAL APPLICATION &

PHARMACEUTICALCOIL

COTTON/RAYON/POLYESTER

DESICCANT INSERT

Saurav AnandIIP, MBA

DESICCANT

DESICCANTS ARE HYGROSCOPIC SUBSTANCE THAT REMOVE MOISTURE FROM ITS SURROUNDING. ENVIRNMENT,OR SAY IT ATTRACT & RETAIN WATER VAPOR TOWARDS ITSELF. Syn; HYGROSCOPY,DELIQUESCENCE,HUMECTANTWORKING 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.

ADSORPTION PHENOMENA

COMMON PRINCIPLEDESICCANT 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

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.

LIST OF COMMON DESICCANT

SILICA GEL INDICATING SILICA GELSMOLECULAR SIEVESDESICCANT CLAY

(MONTMORILLONITE CLAY) CALCIUM OXIDE

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.

MOL. STRUCTURE

Regenerated temp-120 ْ C Adsorb up to one third of its own weight

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

DRYISG

WETISG

NORMALSILICA

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

CONTD….

Muddy powder like

Higher in cost per unit, but extremely large range of adsorptive capabilities.

Manufactured

Gelling process.

Clay process.

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

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

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

COMPARISON SHEET OF DESICCANT

Property Molecular

Sieve Silica

Gel Montmorillonite Clay

CaO CaSO4

Adsorptive Capacity at low H20 Conc.

Excellent Poor Fair Excellent

Good

Rate of Adsorption Excellent Good Good Poor Good

Capacity for Water

@77° F, 40% RH High High Medium High Low

Separation by

Molecular Sizes Yes No No No No

Adsorptive Capacity

at Elevated Temp. Excellent Poor Poor Good Good

COMPARISON GRAPH OF DESICCANT

EQUILIBRIUM H2O CAPACITY

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

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

Choosing the Right Solution for DesiccantTwo 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

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

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

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

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 Humidity6 grams at 40% Relative HumidityA "Unit" At 77°F (25°C)Clay = 33g. Silica gel = 28gMolecular sieve = 28g

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

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)

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.

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,”

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.

Desiccant Plastics: DESICCANT ACTIVE POUCH

CONT.

CONT

TYPE

COTTON REYON POLYESTER

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.

COTTONFEATUERES

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

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.

POLYESTERFEATURES

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.

PHARMACEUTICAL COILFACTS Gram weight - the weight of the coil

per one yard length. Standard industry gram weights 9 grams12 grams16 grams Cotton and rayon coil meets USP and

EP standards

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.