Capsules By: Mr. Girish B - PowerPoint Presentation

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Capsules

By:

Mr. Girish B

KLE

College of Pharmacy,

Belagavi

A constituent Unit of KLE Academy of Higher Education and Research

Nehru Nagar,

Belagavi

–

590 010, Karnataka, India

Phone:

0831-2471399;

Fax:

0831-2472387;

Web:

http

://

www.klepharm.edu

E

-mail:

principal@klepharm.edu

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Are solid dosage forms in which one or more medicinal and or inert substances are enclosed within a small shell or container generally prepared from a suitable form of gelatin. Depending upon their formulation, the gelatin capsule shells may be hard or soft.

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Capsules afford a tasteless, odourless, enclosure convenient for administration of variety of medicaments ,which are otherwise difficult to administer. - All capsules basically consist of soluble shells of a material like gelatin

- The solid substances are dispensed in hard capsules while for dispensing of liquids and semi-solids soft capsules are preferred.

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However, aqueous or hydroalcoholic liquids cannot be enclosed in capsules because they dissolve gelatin - Capsules should not be used for packaging of highly water soluble material such as ammonium chloride, Potassium bromide, KCl because sudden release of such compounds can cause irritation. It is also not advisable to use capsules for very deliquescent or Efflorescent material.

- Deliquescent- draws up moisture from capsule shell rendering it brittle. - Efflorescent – causes softening of the capsule.

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HISTORY1834-Mothes and Dublanc

1848-1st Patent to Murdoch

1st

large scale manufacture- Eli-Lilly &Co in Hampshire U.S.A.1913-Fully automated empty gelatin capsule1950-Filling,sealing,-Semiautomatic1960- Fully automatic

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Characteristics:1. May be swallowed whole by the patient2. May be inserted into the rectum for drug release and absorption from the site

The contents may be removed from the gelatin shell and employed as a pre measured medicinal powder, the capsule shell being use to contain a dose of the medicinal substance. Example: Theo-dur Sprinkle

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4. Elegance5. Ease of use Portability

7. Tasteless shell to mask the unpleasant taste/odor of the drug8. Permits physician to prescribe the exact medication needed by the patient

Conveniently carried10. Readily identified

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11. Easily taken12. Tasteless when swallowed13. Commonly embossed or imprinted on their surface the manufacturer’s name and product

code readily identified14. Available in variety of dosage strength15. Provide flexibility to the prescriber and accurate individualized dosage for the patient

16. Packaged and shipped by manufacturers at

lower cost less breakage than liquid forms17. More stable and longer shelf life8

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Components Of Capsules1. Gelatin

2. FD & C and D & C colorant3. SugarWater - 12 to 16 % but may vary depending on the storage condition

Sulfur dioxide (0.15%) - prevent decomposition during manufacture

6. Opaquants / Opacifying agent - titanium dioxide9

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Variety of grades of gelatin are available which differ in their Gel strength Viscosity iron content

The variations in gelatin properties arise because of changes in molecular weight, and methods followed in conversion into gelatin. Average molecular weight varies between 20,000 – 2,00,000 Pharmagel A- acid processed

Pharmagel B- alkali processed

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For capsule shells generally a mixture derived from pork skin and bones is used. Pork skin gelatin contributes plasticity ; bone gelatin gives

firmness (excess CaPo4 present makes capsule look hazy) Gelatin is exclusively used for manufacture of capsules because of its solubility characteristics in stomach fluids

Plasticizers- methylparaben,propylparaben-0.2%

Not more than 2%-ethyl vanillin, essential oil If sugar is used-upto 5%11

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The capsule shells should be stored under controlled condition of temperature and humidity. Normal moisture content 10-15%-For human use shells are marketed in 8 sizes

Largest being 000Smallest being 5

-Veterinary use 10,11,12

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GELATIN Is obtained by the partial hydrolysis of collagen

obtained from skin, white connective tissue and bones of animals Available in the form of a fine powder, a coarse

powder, shreds, flakes, or sheets Stable in air when dry but when become moist –

subject to microbial decomposition Is insoluble in cold water and soluble in hot water and in warm gastric fluid13

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PROCESS OF MANUFACTURE OF GELATIN USED IN CAPSULES

Dry bone-------5%HCl--------lime10%------lime removal-------pH adjustment

10-15 days 4-8 weeks

bone meal dicalcium phosphate

Calf skin----wash-----------lime 10%--------------water wash 6-12 weeks 10-30 hrsPork skin-------wash--------Acid1-5%HCl---------Acid removal

10-30 hrs

Hot water---Filter---Vacuum---cool to solidfy---air dry----Mill to

extraction concentration size

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Hard Gelatin Capsules

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Hard Gelatin CapsuleMETHOD OF PRODUCTION

Manufactured into 2 sections, the capsule body and the shorter cap

The 2 parts overlap when joined, with the cap fitting

snugly over the open end of the capsule body Shells are produced by chemical dipping of pins or pegs of the desired shape and diameter into a temperature-controlled reservoir of melted gelatin mixture

The pegs made of manganese bronze, are affixed to plates, each capable of holding up to about 500 pegs16

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Each plate is mechanically lowered to the gelatin bath, the peg submerge to the desired depth and maintained for the desired period to achieve the proper length and

thickness of coating The plate and the pegs are slowly lifted from the bath and the gelatin dried by a gentle flow of temperature-

and humidity - controlled air. When dried, each capsule part is trimmed mechanically

to the proper length and removed from the pegs, the capsule bodies and caps are joined togetherHard Gelatin Capsule

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Automatic machine for capsule production consists of mechanisms for automatically dipping spinning drying stripping trimming and joining the capsules.Stainless steel

mold pin on which capsule is formed, controls some of the final critical dimensions of the capsule .

MANUFACTURE OF HARD GELATIN CAPSULES

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MANUFACTURE OF HARD GELATIN CAPSULES

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MANUFACTURING OF HARD GEL CAPSULES

1. Once raw materials have been received and released by Quality Control, the gelatin and hot demineralised water are mixed under vacuum in Stainless Steel Gelatin Melting System.

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2. After aging in stainless steel receiving tanks, the gelatin solution is transferred to stainless steel feed tanks.

MANUFACTURING OF HARD GEL CAPSULES

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3. Dyes, opacifants, and any needed water are added to the gelatin in the feed tanks to complete the gelatin preparation procedure. The feed tanks are then used to gravity-feed gelatin into the Capsule Machine.

MANUFACTURING OF HARD GEL CAPSULES

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4. From the feed tank, the gelatin is gravity fed to Dipper section. Here, the capsules are molded onto stainless steel Pin Bars which are dipped into the gelatin solution.

MANUFACTURING OF HARD GEL CAPSULES

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5. Once dipped, the Pin Bars rise to the upper deck allowing the cap and body to set on the Pins.

MANUFACTURING OF HARD GEL CAPSULES

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MANUFACTURING OF HARD GEL CAPSULES

6. The Pin Bars pass through the upper and lower kilns of Capsule Machine Drying System. Here gently moving air which is precisely controlled for volume, temperature, and humidity, removes the exact amount of moisture from the capsule halves.

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MANUFACTURING OF HARD GEL CAPSULES

7. Once drying is complete, the Pin Bars enter the Table section which positions the capsule halves for stripping from the Pins in the Automatic section.

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MANUFACTURING OF HARD GEL CAPSULES

8. In the Automatic section, capsule halves are individually stripped from the Pins.

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MANUFACTURING OF HARD GEL CAPSULES

9. The cap and body lengths are precisely trimmed to a ±0.15 mm tolerance.

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MANUFACTURING OF HARD GEL CAPSULES

10. The capsule bodies and caps are joined automatically in the joiner blocks.

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MANUFACTURING OF HARD GEL CAPSULES

11. Finished capsules are pushed onto a conveyer belt which carries them out to a container.

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MANUFACTURING OF HARD GEL CAPSULES

12. Capsule quality is monitored throughout the production process including size, moisture content, single wall thickness, and color.

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MANUFACTURING OF HARD GEL CAPSULES

13. Capsules are sorted and visually inspected on specially designed R&J Inspection Stations.

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MANUFACTURING OF HARD GEL CAPSULES

14. Perfect capsules are imprinted with the client logo on high-speed.

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Empty capsule propertyEmpty capsule contain a significant amount of water that acts as plasticizer for the gelatin film and is essential for their function. The standard moisture content specification of HGC is between 12% to 16% w/w.

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Thickness of capsule wall is controlled by the viscosity of the gelatin solution and the speed and time of dipping .Other matters critical to the final dimension are

mold pin dimensions, precise drying, and machine control relating to cut length. Precise control of drying conditions is essential for ultimate quality of cast films.

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Empty capsules are subjected to size variation as a result of moisture content variation. This can be caused by exposure to extreme variations in absolute humidity or elevated temperature. Open storage under either high/low humidity conditions must be

minimized.12-15% suitable moisture content. Below 10% they become

brittle and shrink to the point of not fitting into filling equipment. Above 16%

they may cause size problems in filling equipment, plus loss of mechanical strength. Exposure to either heat or moisture extremes can distort empty gelatin capsules to the extent that they cannot be handled by automatic equipment.37

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The goal is to prepare a capsule with accurate dosage, good bioavailability, ease of filling and production, stability and eleganceThe

active and inactive components must be blended thoroughly to ensure a uniform powder mix for the fillPreformulation studies are performed to determine whether all of the formulation’s bulk powders may be effectively blended together.

Diluent or filler may be added to produce the proper capsule fill volume - ex. Lactose, microcrystalline cellulose and starch

Developing the Formulation and Selection of Capsule Size

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Disintegrants are frequently included in a capsule formulation - to assist the breakup and distribution of the capsule’s contents in the stomach - ex. Pregelatinized starch, croscarmellose, sodium starch glycolateWhen necessary particle size may be reduced by milling to produce particles ranging from 50 to 1000 um

Drugs of lower dose or smaller particles are required, micronization is employed - 1 to 20 um particle size

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The powder mix must be free-flowing to allow steady passage of the capsule fill from hopper and into the capsule shellAddition of lubricant or glidant – fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid or talc (about 0.25-1%) to the powder mix enhances flow properties

Magnesium stearate as lubricant, the water proofing characteristics of this water- insoluble material can retard penetration by the gastrointestinal fluids and delay drug dissolution and absorption

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A surface active agent - sodium lauryl sulfate, is used to facilitate wetting by the Gastrointestinal fluids to overcome the problemInserting tablets or small capsules into capsules are possiblegelatin capsules are unsuitable for aqueous liquids because water softens gelatin and distorts the capsules, resulting leakage of the content

Eutectic mixtures of drugs - tends to liquefy may be mix with a diluent or absorbent such as magnesium carbonate, kaolin or light magnesium oxide to separate the interacting agents and to absorb any liquefied material that may form.41

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Selection of capsule size is done during product developmentThe choice is determined by requirements of formulation, including the dose of the active ingredient and the density and compaction characteristics of the drugs.Hard gelatin capsules are used to encapsulate about 65 mg to 1 g of powdered material

Examples:

1. Powder or granulate in capsule2. Pellet mixture in capsule3. Paste in capsule

4. Capsule in capsule5. Tablet in capsule42

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Powder or granules 4. Capsule

Pellet mixture 5. TabletPaste

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Filling of Capsules

POWDERS

GRANULES

BEADS

TABLETS44

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Filling of Capsules

CAPLETS

PASTES

LIQUIDS

CAPLETS

CAPLETS

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1. Milling /Sieving of all Ingredients2. Blending3. Capsule Filler4. Capsule cleaner / deduster

5. Capsule injection screen6. Capsule check-weighing system/reject7. Finished capsules

8. Packaging

Capsule Filling Process46

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Empty Hard Gelatin Capsule Physical Specifications

Size

Outer

Diameter (mm)

Height or Locked Length (mm)

Actual Volume (mL)

Typical Fill Weights (mg) 0.70 Powder Density

000

9.91

26.14

1.37

960

00

8.53

23.30

0.95

665

0

7.65

21.70

0.68

475

1

6.91

19.40

0.50

350

2

6.35

18.00

0.37

260

3

5.82

15.90

0.30

210

4

5.31

14.30

0.21

145

5

4.91

11.10

0.13

90

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Approximate Capacity Of Capsules

Note: In filling the capsule especially in small number, the method is “PUNCH METHOD”

Capsule Size

Ranging quantity in grains depending on material density

000

10 - 28 grains

00

6 - 20 grains

0

5 - 14 grains

1

3 1/2 - 10 grains

2

3 - 8 grains

3

2 - 6 grains

4

2 1/2 - 4 grains

5

1 1/2 - 2 grains

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Filling Hard Gelatin CapsulesOperations involved:

Rectification of empty capsulesSeparation of caps from bodies

Filling capsule bodies

Replacing caps and ejecting filled capsules49

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FILLING EQUIPMENT

ProFill 100

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With empty capsule in the loader tray, the tray placed on top of the filler unit The loader inserts the capsules into the filling unit and is removed, and the top plate is lifted to separate the caps from the bodies

The powder is placed on the unit and the capsule bodies filled

The top plate is returned to the unit and the caps placed on filled capsule bodies

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Filling

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The empty gelatin capsules from the storage hopper and through the rectifying unit into the two piece filling unit (rectification is based on dimensional differences between the outside diameters of the cap and body portion of capsule)

As the ring is rotated ,a vacuum is applied on its underside (this vacuum seats the bodies into the lower half of the ring, while the caps are retained in the upper portion)

The two pieces of ring are separated, and the cap containing portion is placed aside.

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The body containing portion of the ring is placed on a variable speed turntable and is mechanically rotated under the powder hopper which contains a forced auger for the forced delivery of powder

After one complete rotation of the ring, the powder hopper is removed ,and the two segments of the ring are rejoined

The intact ring is positioned in front of the peg ring and the closing plate is pivoted to a position approx 180 degrees

Pneumatic pressure is applied to the peg ring(forces the capsule body into the cap,and the closing plate) holds the cap in position55

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Ejection of the filled capsules from the rings cannot occur with the plate in closing position

For ejection of the capsules ,the pressure is released ,the closing plate is restored to its original position, and the capsules are expelled through the upper portion of the ring.Normal closing and ejection occur with the peg ring in the vertical position.

Filled capsules collected into a collection chamber.

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SOME OF THE VARIABLES THAT MUST BE CONTROLLED IN ORDER TO ACHIEVE MINIMUM WEIGHT VARIATION AND PROPER UNIFORMITY OF THE FINISHED CAPSULES

The body containing ring must be flat across its surface to avoid creating volumetric differences from one area of the ring to another

The powder hopper must be properly positioned during the filling operation to avoid uneven powder distribution

Extreme variations in powder level in filling hopper can cause uneven powder flow57

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The individual rods in the peg ring must fit the rings being used, be of uniform length, and be perpendicular to the closing plate

Flow properties of the powder being filled must be such that a constant amount of powder is available for delivery from the auger58

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Filling of Pellets

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Filling of Tablets

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Capsule Sealing1.Tamper evident capsules by sealing the joint between the 2 capsule parts2.Distinctive looking capsules by sealing them with colored band of gelatin (Kapseals). If removed, the band cannot be restored without expert sealing with gelatin

3.Through a heat welding process that fuses the capsule cap to the body through the double wall thickness at their juncture - distinctive ring around the capsule where heat welded Example:

Weld’s gelatin seal

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4.Liquid wetting agent that lowers the melting point in the contact areas of the capsule’s cap and the body using low temperatures (40-450C)5.Lightly coating the inner surface of the cap with a warm gelatin solution immediately prior to placement on the filled capsule body.

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Weld’s Gelatin seal fuses the two capsules halves to create one piece capsule that is tamper-evident

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Capsule SealingThe capsule sealing process of banding ( Kapseals, Quali-caps) has been utilized for a number of years. In this process, two capsule parts are sealed with gelatin or polymer band at the seam of the cap and body.Recently, a tamper resistant seal on hard gelatin capsules was developed in which the contact areas of the cap and body are wetted with a mixture of water and ethanol and then thermally bonded at 104

0 to 1130F.

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SEALING OF CAPSULE

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FINISHING

Finished capsules from all filling equipment require some sort of dusting /polishing operation before the remaining operations of

inspection, bottling, and labelling are completed

Pan polishing AccelaCota tablet coating pan may be used to dust & polish capsules. a polyurethane or cheese cloth liner is placed

in the pan ,and the liner is used to trap the removed dust as well as to impart gloss to the capsulesCloth dusting The bulk filled capsules are rubbed with a cloth that may or may not be impregnated with an inert oil.Brushing Capsules are feed under rotating soft brushes ,which

serve to remove the dust from the capsule shell.This operation

must be accompanied by a vacuuming for dust removal

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SPECIAL TECHNIQUESImprinting

Special purpose capsules – to retard the solubility -treated with formalin

-various coating– salol, shellac, cellulose acetate

phthalate and certain resins Separation of incompatible material – use of a 2 phase fill in the capsule

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Compendial Requirements for Capsules1. Added SubstancesHarmless in the quantities used

Do not exceed the minimum amounts required to provide their intended effectDo not impair the product’s bioavailability, therapeutic efficacy or safetyDo not interfere with requisite compendial assays and test

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2. Containers for dispensing Tight, well closed and light resistant containers depending on the item3. Disintegration Test for Capsules

The capsules are placed in the basket rack assembly, which is immersed 30 times per minutes into a thermostatically controlled fluid at 370C and observed over the time described in the individual monograph

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4. Dissolution Test for capsules5. Weight Variation

Hard Capsules - 10 capsules are individually weighed and the content removed. Empty shells are individually weighed and the net weight of the contents calculated by subtraction70

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6. Content Uniformity85% to 115% of the label claim for 9 of 10 dosage units assayed with no unit out side the range of 70% to 125% of label claim7. Content Labeling Requirement

All official capsules must be labeled to express the quality of each active ingredient in each dosage unit8. Stability TestingTo determine the appropriate conditions for storage and the product’s anticipated shelf life

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9. Moisture Permeation TestDetermined by packaging the dosage unit together with a color-revealing desiccant pellet, exposing the packaged unit to known relative humidity over a specified time, observing the desiccant pellet for color change ( indicating absorption of moisture) and comparing the pretest and posttest weight of the package unit

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Inspecting, Counting, Packaging, and Storing Capsules Should have a uniform in appearance Defective capsules should be rejected

Capsules may be counted manually or automated equipment Containers are then mechanically capped, inspected

visually or electronically, labeled, and inspected once more. Packaged in strips, glass or in plastic containers

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Soft Gelatin Capsules

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Soft gelatin capsules

Soft Gelatin capsules are one piece, hermetically sealed. Soft gelatin capsules are made of gelatin, glycerin (or a polyhydric alcohol such as sorbitol) and water etc. to hermetically seal and encapsulate liquids, suspensions, pasty materials, dry powders and even preformed granules, pellets, tablets. They may be manufactured to be oblong, oval or round in shape.

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Easy to administerEasy to Manufacture

Liquids can be encapsulated (water insoluble)Small to large sizes possible

Elegance

PortabilityOdour and taste maskingReady availability of drug hence faster action.

Specialised dosage forms can be made e.g. chewable, extended release, captabs etc.Can be used for ophthalmic preparations e.g. aplicaps, vaginal / rectal suppositories Easily swallowedThe advantages of soft gelatin capsules79

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The disadvantages of soft gelatin capsules

Water soluble material are difficult to incorporate

Highly Moisture sensitive

Efflorescent material cannot be incorporated, they may cause softening / leaching Deliquescent materials cannot be incorporated, they may cause hardening or brittle capsules.

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The pharmaceutical applications of soft gelatin capsules

as an oral dosage form as a suppository dosage form

as a specialty package in tube form, for human and

veterinary single dose application of topical, ophthalmic, and rectal ointments.

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The components

of soft gelatin capsules

1) Gelatin

2) Plasticizer 3) Water 4) Preservative

5) Colorant 6) Opaquants 7) Markings 8) Flavors

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The nature of soft gelatin capsule shellGelatin:

Is pharmacopoeial grade with additional specifications required by the capsule manufacturera) Bloom strength/ Gel strength:

Is a measure of the cohesive strength of the cross-linking that occurs between gelatin molecules and is proportional to the molecular weight of the gelatin. Bloom is determined by measuring the weight (grams) required to move a plastic plunger that is 0.5 inches in diameter 4mm into a 6

2/3 % gelatin gel that has been held at 10°C for 17 hours. Bloom ranges from 150 – 250 grams.84

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b) Viscosity: Generally, 25 to 45 millipoise is acceptable.c)

Iron: ≤15ppm

Plasticizers:

Used to make the soft gel shell elastic. Glycerin or sorbitol or combinations of these. The ratio by weight of water to dry gelatin can vary from

0.7 to1.3(water) to 1.0(dry gelatin). The ratio by weight of dry plasticizer to dry gelatin determines the “hardness” of the gelatin shell and can vary from 0.8/1.Water: NMT 45% w/w

Colour:

may be natural or synthetic - Darker

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The nature of soft gelatin capsule content

1) Liquids

a) Water-immiscible volatile and nonvolatile liquids

vegetable and aromatic oils, aromatic and aliphatic hydrocarbons, chlorinated hydrocarbons, ethers, esters, alcohol and organic acids.b) Water-miscible, nonvolatile liquids

polyethylene glycols, and nonionic surface active agents as polysorbate 80c) Water-miscible and relatively nonvolatile liquids propylene glycol, isopropyl alcohol86

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Liquids that can easily migrate through the capsule

shell cannot be encapsulated into soft gelatin capsules All liquids used for filling must flow by gravity at a

temperature of 35°

c or less. The sealing temperature of gelatin films is 37-40°C.2) Solids

Solutions, suspensions, pasty mass, dry powders, granules, pellets, small tablets 87

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Preservative: Methyl ParabenColour:

used in shell has to be darker than colour of encapsulating material, may be natural or synthetic.Opacifier: usually titanium dioxide, may be added to produce an opaque shell ,when the fill formulation is a Suspension or to prevent photo degradation of light sensitive fill ingredients. Conc. Of opacifier may be up to 0.5%.

Flavors: may be added and up to 5% sucrose may

be included for its sweetness and to produce a chewable shell.88

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The formulation of suspensions for capsulation follows the basic concepts of suspension technology. Formulation technique can be vary depending on the drug substance. In the formulation of suspensions for soft gelatin capsules certain basic information must be developed to determine minimum capsule size. One laboratory tool for this purpose is “Base adsorption”.

Selection of capsule size

Base adsorption is expressed as the number of grams of liquid base required to produce a capsulatable mixture when mixed with one gram of solid

. The base adsorption of solid is influenced by solids particle size, shape, physical status, density, moisture content and its lipophilic or hydrophilic nature.89

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Base adsorption can be determined by

Base adsorption =weight of liquid base

weight of solid

The base adsorption is used to determine the

“minim per gram” (M/g) factorM/g = (BA + S) x V

W

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Manufacturing of Soft Gelatin Capsules

1. Plate-Process: (batch process)

The plates contain die pockets. 1) placing a warm sheet of gelatin on the bottom plate

2) pouring the liquid-containing medications 3) placing the second sheet of gelatin 4) putting the top plate of the mold into place 5) pressing the mold to form, fill, and seal the capsules simultaneously 6) removing and washing the capsule

Today, this equipment can no longer be used.91

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2. The rotary die process (1933, R. P. Scherer) more efficient and productive

Manufacturing of Soft Gelatin Capsules

1) Liquid gelatin is formed into two ribbons

2) The two ribbons are brought together3) Metered fill material is injected between the ribbons4) These pockets of fill-containing gelatin are sealed92

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Rotary die process

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Rotary die process

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Rotary die soft capsule machine

The dies for production of soft capsule

Rotary die process

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Advantages: - capsules can have all kinds of shapes and sizes

- different colors for both sides - wide variety of fills

Disadvantages:

- high amount of shell waste material - longer drying time

Rotary die process96

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3. The reciprocating die process (1949, Norton company)

is similar to the rotary die process in that ribbons of gelatin are formed and used to encapsulate the fill, but it differs in the actual encapsulating process. 1)A set of vertical dies continually open and close to form rows of pockets in the gelatin ribbons.

2)These pockets are filled with the medication and are sealed, shaped, and cut out of the film.

3)The capsules fall into refrigerated tanks which prevent the capsules from adhering to one another.

Manufacturing of Soft Gelatin Capsules97

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Accogel Capsule Machine Or Stern machine (1949, Cyanamid company)

uses a system of rotary dies but is unique in that it is the only machine that can successfully fill dry powder into a soft gelatin capsule.

Manufacturing of Soft Gelatin Capsules

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Manufacturing of Soft Gelatin Capsules

Drying: Infrared drying removes 60-70% of the water.the soft capsules are placed on special trays at 21-24°C and 20-30 % relative humidity.

Sizing: Automatic capsule sizing machine eliminates undersized and oversized capsules.

Inspection: Includes visual inspection to check malformed, damaged or improperly filled capsules.Packaging: Capsule may be packaged in glass or plastic containers or may be strip-packaged - light resistant container

- well-closed container - tight container99

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Product quality considerations

Ingredient specifications - all ingredients of a soft gel

are controlled and tested to ensure compliance with

pharmacopeial specifications.100

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Inprocess testing

During the encapsulation process the four most important tests are:-The gel ribbon thickness

Soft gel seal thickness at the time of encapsulation

Fill matrix weight & capsule shell weightSoft gel shell moisture level and soft gel hardness at the end of the drying stage101

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Finished product testing

These normally includesCapsule appearance

Active ingredient assay & related substances assay

Fill weightContent uniformity Microbiological testing

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Vegicaps®Soft capsules

are an alternative animal free capsule. The shell is made from seaweed extract and gluten free starch, and free from modified sugars or artificial ingredients. The shell can be clear or coloured and there is a wide range of shapes, sizes and colours available.103

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Examples Of Some Official CapsulesOfficial Capsule Commercial Capsule Strengths Category Products usually available

Amoxicillin Wymox 250 and 500 mg AntibacterialAmpicillin Omnipen 250 and 500 mg AntibacterialAspirin 300 mg Analgesic

Cephalexin Keflex 250 and 500 mg Antibacterial

Cloxacillin sodium Tegopen 250 and 500 mg AntibacterialDiphenhydramine Benadryl HCl 25 and 50 mg Antihistamine HClIndomethacin Indocin 25 and 50 mg Antiinflammatory, Antipyretic, analagesic

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REFERENCES

Remington.The Science and Practice of Pharmacy, 21st ed,Vol-1.

Leon Lachman, Lieberman AH, Kanig JL. The Theory and Practice of Industrial pharmacy,4thed.

H.C. Ansel, Introduction to Pharmaceutical Dosage Forms. Michael E Aulton, Pharmaceutics The Science Of Dosage form Design, 2nd ed.

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