Sterile Dosage Form
STERILE DOSAGE FORM
Here we are providing notes of sterile dosage form from pharmaceutics 2
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Parental preparation is a pharmaceutical product that is given by other than oral routes.
Transfusion fluids and injection are parenteral preparation. The injection is the sterile solution or suspension of drugs in an aqueous or oily vehicle meant for introduction into the body by means of an injectable needle under or through one or more layers of the skin or mucous membrane.
The injection should be sterile, isotonic, and free from foreign particles, such as dust, fibers, etc.
ADVANTAGES OF PARENTERAL PREPARATION
1)Onset of action is quick.
2)The drugs which cannot be administered by the oral route, can be administered by this route.
3)the patients who are vomiting or unconscious can not take the drug by the oral route. in such cases, the drug can be administered by this route.
4) the drug action can be prolonged by modifying the formulation.
5) transfusion fluids containing nutrients like glucose and electrolytes such as sodium chloride can be given by this route.
DISADVANTAGES OF PARENTERAL PREPARATION
- The injection causes pain at the site of injection.
- The trained persons are required to administer the drugs.
- The administration of drugs through the wrong route of injection may prove to be fatal.
- It is difficult to save a patient when an overdose is given.
- There are chances of sensitivity reaction of allergic reaction of a drug by an individual. These reactions are sometimes very fatal and lead to death.
GENERAL REQUIREMENTS FOR PARENTERAL DOSAGE FORMS.
- Free from pyrogen
- Freeform foreign particle
- Specific gravity
- Chemical purity
ROUTES OF ADMINISTRATION OF PARENTERAL PRODUCTS
STERILE DOSAGE FORM
The various routes of administration of parenteral preparation are as follows;
- Intradermal ( intracutaneous injection)
These are given in between the dermis and epidermis. The skin of the left forearms is usually selected for giving the injection. Generally, 0.1 to 0.2 of the parenteral solution is injected by this route. the route is used for diagnostic purposes and for testing the sensitivity of the injectables.
- Hypodermis ( subcutaneous ) injection l
-these are made under the skin, into the subcutaneous tissue.
-the volume of 1.0 ml or less, is usually injected into the upper arms.
-this is the most popular route because it is convenient for the patient and the doctor.
- intramuscular injection
-these injections are given into the muscular tissues.
-the muscles of the shoulder, thigh, or buttock are usually selected.
-generally, volume up to 2.0 ml is administered by this route and should not exceed 4.0 ml at one site.
– aqueous or oily suspensions and oily solution can be administered by this route.
- Intravenous route
-these injections are made into a vein and therefore introduced directly into the bloodstream.
– the median basilic vein near the anterior surface of the elbow is usually selected because it is easily located and connects with the major veins of the arm.
– large volume of parenteral solution ranging from 1 ml to 500 ml or more than that can be injected.
– the parenteral solution should be isotonic with blood if the volumes of more than 15 ml should be injected.
-the suspension and oily injections cannot be injected by this route.
- Intraarterial injections-
- These are similar to intravenous injections and are occasionally used for an immediate effect in a peripheral area.
- These injections are given directly into the artery.
- Intracardiac injections-
- These are given into the heart muscle or ventricles in an emergency only
– for example; as a stimulant following cardiac arrest.
- Intrathecal injections
-these are made into subarachnoid space that ventricle in an emergency only
-this route is used for giving spinal anesthesia.
- intracisternal injection
-these are given in between the first and second cervical vertebrae.
-this route is used to withdraw c.s.f. ( cerebrospinal fluid) for diagnostic purposes.
- peridural injections.
-these are given between the dura mater and the inner aspects of the vertebra.
-so it is that portion of the vertebral canal not occupied by the dura mater and its contents.
– this route is sometimes used for giving spinal anesthesia in special cases.
- intra- articular injections
– these injections are given into the liquid that lubricates the articulating ends of bones in a joint.
- intracerebral injections
– these injections are given into the cerebrum.
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STERILE DOSAGE FORM
TYPES OF PARENTERAL SOLUTION
-Solution or emulsions of medicaments suitable for injections.
FORMULATIONS OF PARENTERAL PREPARATIONS
– solubilizing agents
– antibacterial agents
– chelating agents
– suspending, emulsifying, and wetting agents
– tonicity factors
PROCESSING OF PARENTERAL PREPARATIONS
The following steps are involved in the processing of parenteral preparations;-
- Cleaning of containers, closure, and equipment
- Collection of material
- Preparation of parenteral products
- Filling the preparation in the final container
- Sealing the container
- Evaluation of parenteral preparations
- Labeling and packaging
1.cleaning of containers, closure, and equipment-
-all the containers, closure, and equipment that are required during the preparation of parenteral products are thoroughly cleaned with detergents, and washing is done with tap water for injection.
– rubber closure is washed with hot solution 0.5% sodium pyrophosphate in water.
– the closure is then removed from the solution, wash with water followed by rinsing with filtered water for injection.
-on a small scaler washing is done manually but on a large scale, automatic washing machines are used.
collection of materials-
-the various ingredients of the formulation of parenteral preparation are weighed and collected in the preparation room.
– the raw materials required in the preparation of parenteral products should be pure.
-water for injection free from pyrogens and micro-organisms is used in the preparation of parenteral products.
3.preparation of parenteral product
-the pharmacist should decide the order of mixing and the exact method of preparation to be followed before preparing the parenteral products.
-the parenteral preparations must be prepared under strict aseptic conditions.
– the ingredients are accurately weighed separately and dissolved in the vehicle as per the method of preparation to be followed.
STERILE DOSAGE FORM
– the parenteral solution so formed is passed through bacteria-proof filters, such as filter candles, Seitz filters, membrane filters, and sintered glass filters.
– the primary objective of filtration is to clarify the solution by removing foreign particles.
-if the parenteral preparation is required to be sterilized by means of bacteria proof filters.
-filtration should be done under strict aseptic conditions to avoid contamination of the filtered solution before it is finally transferred into a final container and sealed.
5.filling and preparation in final containers
-the filter product is filled into final containers such as ampoules, vials, and transfusion bottles, which are previously cleaned and dried.
-ampoules are used for filling single doses whereas, vials are used for filling multi dose.
-bottles are meant for filling transfusion fluids.
-on small scale, the filling is done manually is done by an automatic filling machine.
-the sterile powders are filled into containers by individual weighing or by using automatic or semi-automatic devices.
– the filling operation is carried out under strict aseptic precautions.
-during the filling of ampoules, care should be taken that the solution should not touch the neck of the ampoules.
-this will prevent the cracking and staining of the neck of ampoules at the time of sealing.
6.sealing the containers
– sealing should be done immediately after filling.
-ampoules are sealed manually on a small scale by rotating the neck of the ampoules in the flames of the bunsen burner.
– but on large-scale ampoules sealing machine is used in which the tip of ampoules is fused to seal it.
– vials and transfusion bottles are sealed by closing their opening with a rubber closure.
– the rubber closures are held in place by crimping the aluminum caps which is done manually or by mechanical means.
-the parenteral preparation should be immediately sterilized after sealing in its final containers.
-the sterilization is done by any one of the methods of sterilization which depends on the nature of medicaments present in parenteral preparations.
– for thermostable medicaments, the parenteral products are sterilized either by autoclaving at a temperature of 115 to 116 dc for two hours.
– the thermolabile preparations are sterilized by filtration through suitable bacteria proof filters.
-parenteral preparation which is sterilized by filtration method may contain a suitable bacteriostatic agent to prevent the growth of micro-organisms.
-when the solutions are used for intravenous or intrathecal injection in doses exceeding 15 ml, the bacteriostatic agent should not be used.
-the sterilized product is filled into the final containers and sealed.
-the process of filtration, filling, sealing are done under aseptic conditions.
8.evaluation of parenteral preparation.
– the finished parenteral products are subjected to the following tests in order to maintain quality control
1) sterility test- all the parenteral preparations which are supplied in the sterile form must confIrm to the test for sterility as prescribed in the pharmacopeia.
The test for sterility is done by detecting the presence of viable forms of bacteria, fungi, and yeast in parenteral preparation. The sterility test must be carried out under strict aseptic conditions in order to avoid accidental contamination of the product during the test.
All glassware required for the test must be sterile. Culture media required for the growth of aerobic, anaerobic and fungi, are prepared as described in the pharmacopeia.
The test for sterility may be carried out either by-
- Membrane filtration method
- Direct inoculation method.
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2) clarity test– clarity test is performed to ensure that the parenteral products are free from foreign particles. each parenteral preparation in its final containers is subjected individually to a visual inspection to exclude the possibility of foreign particles.
4) pyrogen test
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