STERILE DOSAGE FORM
HELLO GUYZZ, here we are providing notes of sterile dosage form from pharmaceutics 2
these points will be easy to understand and remember all these notes are taken from books and some of the help of google, so let’s begin…..
Parental preparation is a pharmaceutical product that is given by other than oral routes.
Transfusion fluids and injection are parenteral preparation. Injection are the sterile solution or suspension of drugs in 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.
injection should be sterile, isotonic and free from foreign particles, such as dust, fibres etc.
ADVANTAGES OF PARENTERAL PREPARATION
1)Onset of action is quick.
2)The drugs which cannot be administered by oral route , can be administered by this route.
3)the patients who are vomiting or unconscious can not take drug by oral route . in such cases the drug can be administered by this route.
4) the drug action can be prolongs by modifying the formulation.
5) transfusion fluids containing nutritives like glucose and electrolytes such as sodium chloride can be given by this route.
DISADVANTAGES OF PARENTERAL PREPARATION
- Injection causes pain at the site of injection.
- The trained persons are required to administer the drugs.
- The administration of a drugs through wrong route of injection may prove to be fatal.
- It is difficult to save a patient when over dose 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
- Free form foreign particle
- Specific gravity
- Chemical purity
ROUTES OF ADMINISTRATION OF PARENTERAL PRODUCTS
The various routes of administration of parenteral preparation are as follows;
- Intradermal ( intracutaneous injection)
These are given in between dermis and epidermis. Skin of the left forearms is usually selected for giving the injection. Generally 0.1 to 0.2 of parenteral solution is injected by this route . the route is used for diagnostic purpose 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 upto 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 blood stream.
– the median basilic vein near the anterior surface of the elbow is usually selected, because it is easily located and connect 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.
- Intra- arterial 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 subarchnoid space that ventricle in an emergency only
-this route is used for giving spinal anaesthesia.
- 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 duramater and the inner aspects of the vertebra.
-so it is that portion of vertebral canal not occupied by the duramater and its contents.
– this route is sometimes used for giving spinal anaesthesia in special cases.
- intra- articular injections
– these injections are given into the liquid that lubricate the articulating ends of bones in a joint.
- intracerebral injections
– these injections are given into cerebrum.
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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 equipments
- Collection of material
- Preparation of parenteral products
- Filling the preparation in final container
- Sealing the container
- Evaluation of parenteral preparations
- Labelling and packaging
1.cleaning of containers, closure and equipments-
-all the containers, closure and equipments which are required during the preparation of parenteral products are thoroughly cleaned with detergents and washing is done with tap water for injection.
– rubber closure are washed with hot solution 0.5% sodium pyrophosphate in water.
– the closure are then removed from the solution, wash with water followed by rising 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 are used in the preparation of parenteral products.
3.preparation of parenteral product
-the pharmacist should decide the order of mixing and 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 method of preparation to be followed.
– the parenteral solution so formed is passed through bacteria proof filter, such as, filter candle, seitz filter, membrane filter, and sintered glass filters.
– the primary objectives of filtration is to clarify the solution by removing foreign particles.
-if the parenteral preparation are required to be sterilized by means of bacteria proof filters.
-filtration should be done under strict aseptic condition to avoid contamination of filtered solution, before it is finally transferred into 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 multidoses.
-bottles are meant for filling transfusion fluids.
-on small scale, filling is done manually is done by 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 pf ampoules, the 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 thee neck of the ampoules in the flames of bunsen burner.
– but on a large scale ampoules sealing machine is used in which tip of ampoules is fused to seal it.
– vials and transfusion bottles are sealed by closing its opening with a rubber closures.
– the rubber closures are held in place by crimping the aluminium caps which is done manually or by mechanical means.
-the parenteral preparation should be immediately sterilised after sealing in its final containers.
-the sterilisation is done by any one of the methods of sterilisation which depends on the nature of medicaments presents in parenteral preparations.
– for thermostable medicaments, the parenteral products are sterilised either by autoclaving at a temperature of 115 to 116 dc for two hours.
– the thermolabile preparations are sterilised by filtration through a suitable bacteria proof filters.
-parenteral preparation which are sterilised 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 sterilised product is filled into the final containers and sealed.
-the process of filtration, filling, sealing are done under aseptic condition.
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 sterile form must confirm to the test for sterility as prescribed in the pharmacopoeia.
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 glass wares required for the test must be sterile. Culture media required for the growth of aerobic, anaerobic and fungi, are prepared as described in pharmacopoeia.
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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