3.0 APPARATUS : Capsule Machine, Analytical balance, Spatula, Beaker, Pestle and mortar, Powder paper.

Transcription

1 1.0 TITLE OF EXPERIMENT : - Herbal Capsule 2.0 OBJECTIVE OF EXPERIMENT : - To understand how to prepare capsule. 3.0 APPARATUS : Capsule Machine, Analytical balance, Spatula, Beaker, Pestle and mortar, Powder paper. 4.0 MATERIALS : Phenobarbital, Capsule, Ephedrine Sulfate, Codeine phosphate, Aspirin, Acetophenetidine, Caffeine, Atropine sulfate, Lactose. 5.0 PROCEDURE OF EXPERIMENT : Experiment A: Preparation of Ephedrine Sulfate and Phenobarbital Capsules Ephedrine Sulfate g Phenobarbital g. Make 6 capsules Sig.: one cap. q.i.d. Use : treatment of bronchial asthma 1. The powders are triturated intimately and mixed by geometric dilution 2. The resting powder is placed on a powder paper and smoothed with a spatula to a height approximately half the length of capsule body. 3. The open end of the capsule base is repeatedly pushed into the powder until the capsule is filled 4. The cap. is then placed back to close the capsule. 5. Each filled capsule is weighed using empty capsule as counterpoise, powder is added or removed until the correct weight is obtained. 6. Finally the capsule is cleaned to remove any trace of powder trapped on the surface Calculation Calculate for 10 capsules using no. 0 capsules 1. Fill one capsule with lactose in previously described manner and determine the exact capacity of capsule by weighing suppose it is 0.5 g. 2. Calculate the amounts drugs for 10 capsules and substrate from total amount of lactose (0.5 g x 10 ) to get amount of lactose which you will use e.g. ( 0.5 g x 10 (0.025 x x 10 ) ) = 4.6 g lactose 3. Weigh the calculated amounts of lactose ( 4.6 g ), ephedrine sulfate (0.25 g ) and Phenobarbital ( 0.15 g ).

2 6.0 RESULT : Take note every observation and step been taken during the practical. Capsule # Capsule Weight Weight A + B Remarks DISCUSSION Discuss possible error occur during practical that can affect your results. 8.0 CONCLUSION Conclusion of your experiment 9.0 REFERENCE : In APA format

3 Extra Information: Introduction Capsules are gelatin shells filled with the ingredients that make up an individual dose. Dry powders, semi-solids, and liquids that do not dissolve gelatin may be encapsulated. Capsules account for about 20% of all prescriptions dispensed. Capsules have several advantages as pharmaceutical dosage forms: 1. They may be used to mask the unpleasant tastes, aromas, or appearance of a drug. 2. They allow powders to be dispensed in an uncompressed form, thus allowing for quicker dissolution and absorption of the drug following oral dosing (as compared with tablets). 3. They offer the pharmacist versatility to prepare any dose desired for a variety of administration routes (e.g. oral, inhalation, rectal, or to be diluted for vaginal, rectal, oral or topical use). 4. They may be easier than tablets for some people to swallow. 5. They can be make to alter the release rate of the drug. Their disadvantages or limitations include the following: They are easily tampered with (although techniques exist for preventing this). They are subject to the effects of relative humidity and to microbial contamination. They may be difficult for some people to swallow. More expensive (commercially). Hard Gelatin Capsules: The hard gelatin capsule consists of a base or body and a shorter cap, which fits firmly over the base of the capsule. For human use, eight sizes of capsules are available. The capacity of each size varies according to the combination of drugs and their apparent densities. Capsules are available as clear gelatin capsules or in a variety of colors. The pharmacist can use the different colored capsules to distinguish two capsule formulations for the same patient, or to encapsulate unattractive ingredients. The pharmacist can add a dye to the powder before filling a clear capsule to impart a color for identification or esthetics. Some types of hard gelatin capsules have a locking cap, which makes it more difficult to reopen the capsule. To aid in the selection of the appropriate size, a table, with the capacity of five common drugs for that particular size capsule, is printed on the box of the capsules. As a guide, the relative sizes and fill capacities of capsules are given below. By knowing the bulk density of fill material, proper choice of capsule size is usually made easier; however, trial and error soon develops the judgment of the beginning pharmacist.

4 Capsule Size Volume ( ml) Mg of Lactose Mg of Aspirin Punch Method To hand fill capsules at the prescription counter, the pharmacist generally uses the "punch" method. The ingredients are triturated to the same particle size and then mixed by geometric dilution. The powder is placed on a powder paper or ointment slab and smoothed with a spatula to a height approximately half the length of the capsule body. The base of the capsule is held vertically and the open end is repeatedly pushed or "punched" into the powder until the capsule is filled; the cap is then replaced to close the capsule. Each filled capsule is weighed using an empty capsule as a counterweight. Powder is added or removed until the correct weight has been placed in the capsule. The filled capsule is tapped so that no air spaces are visible within the contents. It is a good practice to remove from the stock container the exact number of empty capsules needed before you begin filling them. In this way you avoid preparing the wrong number of capsules and at the same time avoid contaminating the empty capsules with drug particles that cling to your hands. Also, since some fill material will likely be lost in the process of punching capsules, the pharmacist generally calculates for the preparation of at least one extra capsule to insure enough fill for the last capsule. The simplest method by which a capsule may be kept free of moisture during compounding is to wash the hands well, dry them, and keep the fingers dry by stripping a towel through the cleansed fingers until warmth is felt. An alternative method is to use the base of one capsule as a holder for other bases during the filling operation. The capsules do not come in contact with the fingers. The most sure method of protecting the capsule is to wear finger cots or rubber gloves. Capsule Machines Capsule machines are available for filling 50, 100, and 300 capsules at a time. Each manufacturer's machine is slightly different in its operation, but the series of operations is the same. Capsules are first loaded into the machine. Most machines come with a capsule loader which correctly aligns all of the capsules in the machine base. There are plates on the machine base that can be adjusted. First, the plates are adjusted to hold the capsule bodies in place while the caps are removed all at one time. The caps remain in place in the top of the machine for later use. Then the plates are adjusted again so that the capsule bodies will "drop" into place so that the tops are flush with the working surface of the plate. The formulation powder is poured onto the plate and special spreaders and combs are used to fill the individual capsules. Some manufacturer's have special shakers that will also help spread the powder and fill the capsules. The powder is spread evenly over the plate, and the comb is used to tamp and pack the powder into the capsules. These two processes are

5 repeated over and over again until the capsule bodies are filled with the powder. All of the caps are then simultaneously returned to the capsule bodies, and the closed capsules are removed from the machine. The machine has the advantage of filling many capsules in a timely manner. However, there is a tendency to pack the capsules in the middle of the plate with more powder than the capsules along the periphery. It takes practice to ensure that each capsule has the same amount of drug. A quality control procedure should be executed with each batch of capsules produced with the machine. Final Processing Once the capsules have been compounded and the capsule closed, the pharmacist may want to "seal" the capsule. The best way is to use "locking" capsules, where the body and cap lock together, making it very difficult to open the capsule again. If using locking capsules, during the filling process the cap is not completely closed onto the body in the weighing procedure to determine the weight of powder in the capsule. The locking is done only one time and that is after the capsule is correctly filled. If locking capsules are not used, a seal can be made by touching the outer edge of the body with a moist towel to soften the gelatin. Alternatively, a cotton swab dipped in warm water can be rubbed around the inner edge of the cap. When the cap is closed on the body, it is slightly twisted to form the seal. When compounding and sealing are complete, the capsules may need cleaning to remove fingerprints, traces of body oils, or loss powder from the capsule. Fingerprints and oils cannot be effectively cleaned from capsules so the best way to prevent these problems is to wear gloves during the compounding process. Any clinging powder can be removed by rolling the capsules between the folds of a towel. Another proposed cleaning method is to put the capsules in a container filled with sodium bicarbonate, sugar, or sodium chloride, and gently roll the container. Then the container contents can be poured into a ten-mesh sieve where the "cleaning salt" will pass through the sieve. Capsules should be visually inspected and checked for: Uniformity - check capsules for uniformity in appearance and color. Extent of fill - check capsules for uniformity of extent of fill to ensure that all capsules have been filled. Locked - check capsules to ensure that they have all been tightly closed and locked.

6 Additional Considerations Capsules are made of gelatin, sugar, and water and contain about 10% to 15% moisture. Gelatin can absorb up to ten times its weight in water. So if gelatin capsules are placed in areas of high humidity, they will become malformed or miss happened as they absorb moisture. On the other hand, if capsules are placed in low humidity, they become dry and brittle and may crack. To protect capsules from the extremes of humidity, they should be dispensed in plastic or glass vials and stored in a cool, drug place. It appears that a storage relative humidity of 30% to 45% is best. Cotton can be placed in the top of the vial to keep the capsules from rattling. If powders that are being mixed before encapsulation are very light and fluffy and "difficult to manage," add a few drops of alcohol, water, or mineral oil. As an alternative, mix these powders in a plastic bag. If the powders seem to have a "static charge," use about 1% sodium lauryl sulfate. Magnesium stearate (less than 1%) can be added to powders to increase their "flow ability" which makes filling capsules easier. However, magnesium stearate is a hydrophobic compound and may interfere with the dissolution of the powders.