Capsules (Pharmaceutics)

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Capsules V V S Narayana Reddy Karri Lecturer Dept of Pharmaceutics JSS College of Pharmacy, Ootacamund ( JSS University, Mysuru ) Rocklands Udhagamandalam.

Advantages :

Advantages The drugs having unpleasant odour and taste can be administered by enclosing them in a tasteless shell . They are smooth and can be easily swallowed They are economical They are easy to handle and carry They are attractive in appearance Disadvantages The hygroscopic drugs cannot be filled in to capsules. Because they absorb the water present in the capsule shell and hence make it very brittle . The concentrated preparations which need previous dilution are unsuitable for capsules because it may lead to irritation in stomach if administered as such.

Types of capsules:

Types of capsules Hard gelatin capsules Soft gelatin capsules

1. Hard gelatin capsules:

1. Hard gelatin capsules These are used for administration of solid medicaments The capsule shell is prepared from gelatin . It consists of two parts i.e body and cap . The powdered material is filled into the cylindrical body of the capsule and then the cap is placed over it . The empty capsules are available in various sizes . They are numbered according to the capacity of the capsules . The number starts from 000 and goes up to 5 . The approximate capacity of a capsule with respect to its number is given in the following table:

Capsule number and its approximate capacity:

Capsule number and its approximate capacity Capsule number Approximate capacity in mg 000 950 00 650 0 450 1 300 2 250 3 200 4 150 5 100

Excipients used in the filling of capsules:

Excipients used in the filling of capsules While filling solid medicaments in a powder form into the body of a hard gelatin capsule ,the following additives, are included in the formulation: DILUENTS The diluent is needed in certain cases where the quantity of the medicament is too small in bulk to get it filled in the smallest available capsule size . In such cases, diluent is added to bring the medicament upto the desired bulk. e.g., The commonly used diluents are lactose, mannitol,sorbitol,starch etc. 2. ABSORBENT S Sometimes the medicaments are physically incompatibile with each other e.g., eutectic substances or hygroscopic substances. In such cases, absorbents, such as oxides and carbonates of magnesium and calcium and kaolin are added to the powdered drug. These inert materials act as a protective sorbent. 3. GLIDANTS To ensure a regular flow of powder into the automatic capsule machine glidants are mixed with the medicaments. The various glidants used for this purpose are talc, magnesium stearate and calcium stearate . 4. ANTIDUSTING COMPOUNDS During the filling of capsules by an automatic filling machine, a lot of dust comes out the machine . The dust is inhaled by the operator of the machine. It can pose a serious health hazard if allowed to be unchecked, especially, when the dust of the potent drugs is inhaled by the workers. To avoid this, some antidusting components, like inert edible oils , are added to the formulation.

Methods of filling of the hard gelatin capsules:

The capsules can be filled either by hand or by a semi-automatic device or by automatic filling machine . A. CAPSULE FILLING MACHINE (HAND OPERATED) It consists of :- 1. A bed having 200-300 holes 2. A loading tray having 200-300 holes 3. A powder tray 4. A pin plate having 200-300 pins 5. A sealing plate having a rubber top 6. A lever 7. A cam handle Methods of filling of the hard gelatin capsules

Methods of filling of the hard gelatin capsules…:

Methods of filling of the hard gelatin capsules… The empty capsules are filled in the loading tray and it is placed over the bed. The cam handle is operated to separate the capsule caps from their bodies. The powder tray is placed in a proper position and filled with an accurate quantity of powder with scraper. The excess of powder is collected on the platform of the powder tray. The pin plate is lowered and the filled powder is pressed by moving the pin downwards. After pressing, the pin plate is raised and the remaining powder is filled into the bodies of capsules. The powdered tray is removed after its complete filling. The cap holding tray is again placed in position. The plate with the rubber top is lowered and the lever is operated to lock the caps and bodies. The loading tray is then removed and the filled capsules are collected. With a 200 hole machine, about 5000 capsules can be filled in one hour, whereas in a machine having 300 holes, about 7500 capsules can be filled in one hour.

Slide 9:

CLEANING OF CAPSULES All capsules, whether they have been filled by hand or machine, will require cleaning. Small quantities of capsules can be wiped individually with soft cloth. But in case of large quantities, capsules are rotated or shaken with crystalline sodium chloride . The capsules are then rolled on cloth covered surfaces . SEALING OF CAPSULES The capsules are then sealed, to ensure that the medicaments may not come out of the capsule due to rough handling. This can be done by banding them with molten gelatin , laid around the joint in a strip and dried. Capsules can be sealed by spot welding , by means of a heated metal pin, pressed against the cap and fusing it to the body.

2. Soft gelatin capsules:

2. Soft gelatin capsules These are used for administrations of liquid medicaments . Soft gelatin capsules are available in round, oval and tube like shapes. They are made from gelatin . The gelatin is plasticized by the addition of glycerin and sorbitol etc. The soft gelatin shell may contain a preservative to prevent the growth of fungi . They are used to enclose liquid medicaments such as oils, suspensions, food concentrates and ophthalmic products .

Methods of filling of soft gelatin capsules:

Methods of filling of soft gelatin capsules ROTATORY MACHINE In a rotary die machine, the soft gelatin capsules are prepared and then filled immediately with the liquid medicaments. The machine consists of two hoppers . Liquid gelatin mixture is placed in one hopper and the liquid medicament in the other hopper. There are two rotating dies which rotate in opposite directions. When fluid gelatin mixture enters into the machine from the hopper, it produces two continuous ribbon . These ribbons come over the rotating dies from opposite directions and enter in between the dies . Thus, half shell of the capsule is formed. At this stage the measured quantity of the medicament is filled into it with the stroke of a pump. With the subsequent movement of the dies, the other half of the capsule is formed. The two halves of the capsules are sealed together by the heat and pressure of the raotating dies. The capsules formed are washed throughly and dried. These rotary machines are capable of producing between 25000 and 30000 capsules in an hour.

Differentiate b/w Hard and Soft gelatin capsules:

Hard gelatin capsules Soft gelatin capsules The hard gelatin capsule shell consists of two parts: a) Body b) Cap The soft gelatin capsule shell becomes a single unit after sealing the two halves of the capsules. They are cylindrical in shape . They are available in round, oval and tubes like shapes. The content of a hard gelatin capsule usually consist of the medicaments in the form of the powder, beads or granules . The contents of soft gelatin capsules usually consist of liquid s or solids dissolved or dispersed in suitable excipients to give a paste-like consistency. These are prepared from gelatin , titanium dioxide, colouring agent and plasticizer. These are prepared from gelatin , plasticizer ( Glycerin or Sorbitol ) and a preservative. Capsules are sealed after they are filled to ensure that the medicaments may not come out of the capsule due to rough handling. Filling and sealing of soft gelatin capsules are done in combined operation on machines. Differentiate b/w Hard and Soft gelatin capsules

Special application of capsules:

Special application of capsules Enteric coated capsules Sustained release capsules Rectal capsules Capsules containing ophthalmic ointments

1. Enteric coated capsules:

1. Enteric coated capsules These capsules do not disintegrate in stomach (acidic medium) but break-up in the intestine (alkaline medium). A special type of coating is given on the capsules so that these can pass unchanged through the stomach but get disintegrated in the intestine . The following categories of drugs need enteric coating Drugs which cause irritation to the gastric mucosa Drugs which destroy the gastric juices Drugs which are intended to act in intestine e.g. amoebicides and anthelmintics Enteric: occurring in the intestines

2. Sustain release capsules:

2. Sustain release capsules In order to maintain blood concentration of the medicament and reducing the number of doses per day , a capsule containing numerous coated pellets is administered that release the drug successively over a long period . First the medicament powder is converted in to pellets and these pellets are coated for prolong release of drug.

3. Rectal capsules:

3. Rectal capsules Soft gelatin capsules may be used as substitutes for rectal and vaginal suppositories . Both liquid and solid medicaments can be filled into such capsules provided that the base for incorporating the medicament is non-toxic, non-irritant and compatible with capsule shell.

4. Capsules containing ophthalmic ointment:

4. Capsules containing ophthalmic ointment These, Ophthalmic ointments are filled in to capsules. These capsules are intended for a single application to the eye. The capsule is punctured with a sterile needle and its contents are instilled in to the eye and afterward the capsule shell is discarded .

Packing and storage of capsules:

Packing and storage of capsules Capsules should be packed in well-closed glass or plastic containers and stored at a temperature not exceeding 30 o C . They should be comply with storage requirements specified in the individual monographs given in the Indian Pharmacopeia. Capsules can be individually protected by enclosing them in a strip or blister packs .

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