STERILE FORMULATION 

 

Sterile is a term that has a relative connotation, and the possibility of creating  absolute conditions free of microorganisms can only be estimated by kinetic  projections of the microbial mortality rate. Sterilization is a process designed to  create a sterile state. Traditionally, sterile conditions are absolute conditions created  as a result of the destruction and elimination of all living microorganisms. 

Sterile preparations are therapeutic preparations that are free of  microorganisms, either vegetative or in their spore form, either pathogenic or non pathogenic. A sterile product is a therapeutic preparation in a divided form that is free from live microorganisms.

The formulation of sterile preparations is one of the widely used  pharmaceutical dosage forms, especially when patients are hospitalized. Sterile  preparations are very helpful when the patient is operated on, infused, injected, has an  open wound that must be treated, and so on. All of them are in dire need of sterile  conditions because medication that is directly in contact with body cells, mucous  layers of body organs, and is inserted directly into body fluids or cavities is very  likely to cause infection if the drug is not sterile. Therefore, we need sterile drug  preparations. Besides being sterile, we also need drug preparations in isohydric and  isotonic conditions so as not to irritate.

To produce sterile preparations, we need additional knowledge besides  knowledge of the manufacture of dosage forms, namely the assurance that during  production and after production, the preparation is free from microbial contamination.  Sterile dosage forms can be in various forms, namely liquid, solid, or semisolid. One  example of a sterile preparation in question is injection. Injection is a sterile  preparation in the form of a solution, emulsion, suspension, or powder that must be  dissolved or suspended before use. Injection also has various types according to its  use. 

Drugs that must be sterile are parental solutions, ophthalmic drugs,  radiopharmaceutical preparations, solutions for irrigation, allergenic extracts, and  diagnostic agents. A preparation must be sterile because it is in direct contact with the  body, especially fluids such as blood vessels, because body fluids do not have a  strong enough resistance. 

 

Kinds Of Steril Preparations 

✔ Based on Packaging 

1.    Single unit dose: injection in ampoules 

2.    Multiple dose: injection in vial

3.    Large volume fluids: intravenous  infusion 

✔ Based on usage 

1.    Injection 

A drug solution in a suitable carrier with or without additives  intended for parenteral use 

2.    Infusion Fluid 

Is a special injection because of  the way it is given and the volume  is large Useful for: 

a.    Basic nutrition Dextrose  infusion

b.    Repair of electrolyte balance  Ringer's infusion Contains  Na+, K+, Ca2+ and Cl- ions 

c.    Replacement for body fluids  Infusion of dextrose and NaCl 

d.   Assist in the diagnosis of renal  function determination  Mannitol injection 

3.    Radiopharmaceutical 

a.    An injection containing  radioactive material. Serves for  diagnosis and treatment in  organ tissue. 

b.    Manufacture and use is  different from ordinary  medicinal materials (non radioactive) 

c.    Example: Amphotericin B  Injection 

4.    Dry solid 

a.    Materials that are unstable in  liquid/solution form are stored  in the form of dry solids which  are dissolved at the time of use. 

If the dry solid contains no  buffers, diluents or other  additives, and when other  suitable solvents are added,  give a solution that meets all  aspects of the requirements for  an injectable drug. Preparations  are labeled as sterile drugs. 

b.    Example: Ampicillin Sodium  Sterile 

If the dry solid contains one or  more buffers, diluents or other  additives, the preparation is  labeled as an injectable drug. 

5.    Irrigation Solution 

a.    Requirements such as  parenteral solution 

b.    Packaged in a large volume  container with a rotating lid

c.    Used for soaking  wounds/washing wounds,  surgical incisions or body  tissues/organs 

d.   Labeled the same as the  injection. 

e.    Example: Sodium chloride for  irrigation, sterile water for  irrigation 

f.     Label / etiquette: "not for  injection drugs"

6.    Dialysis Solution 

a.    To remove toxic compounds  that are normally secreted by  the kidneys. 

b.    Dialysis is a process, in which  compounds can be separated  from one another in solution  based on differences in their  ability to diffuse through a  membrane. 

c.    The dialysis solution contains  dextrose as the main source of  calories, vitamins, minerals,  electrolytes, and amino  acids/peptides as a nitrogen  source. 

7.    Diagnostic Material 

a.    Diagnostics is one of the  methods of examination in the  science of preventive medicine  (preventive medicine)  infectious diseases, based on  the reaction between an  antibody and the antigen in  question. 

b.    An intracutaneous (over the  skin) injection is used  (immunity skin test) with an  

a.    antigen at the lowest level that  allows a reaction to occur. 

c.    A positive reaction in the form  of a kind of lump on the skin,  indicates that the body already  contains certain antibodies. 

d.   A negative reaction means that  the body does not have these  antibodies, in this case the  person must be vaccinated to  increase the body's immunity  actively 

e.    Tuberculin reaction, is one of  the well-known immune tests  for diagnosing tuberculosis  (Mantoux skin test) 

8.    Allergy Extract → Allergen  Extract 

Is a sterile concentrated solution  of allergens for the purpose of  diagnosis or treatment of allergic  reactions 

9.    Solutions, suspensions and  ointments for the eyes 

Drugs in solution or suspension  that are administered by drip into  the eye are sterile preparations,  although the term sterile is usually  not included in the name, such as: “Sulfacetamide ophthalmic  solution” or Hydrocortisone  Acetate Ophthalmic suspension. 

10.     Eye Ointment 

a.    Eye ointment preparations are  in the form of medicinal  ingredients in the form of  dissolved or powder made fine  to micron size added to the  base of the eye ointment that  does not cause irritation. 

b.    Ophthalmic ointments are  sterilized by dry heating (oven)  or radiation. 

c.    Some are prepared as sterile  preparations by aseptically  combining sterile elements. 

d.   Container: a closed place  (pointed-mouth tube), free of  metal. 

e.    Example: Gentamicin Sulfate  eye ointment 

11.     Sterile pellet or subcutaneous  implant 

a.    Pellets or sterile implants are  cylindrical, small, solid tablets  with a diameter of  approximately 3.2 mm and a  length of 8 mm, made by  compression and intended to be  implanted subcutaneously  (thigh or abdomen) for the  purpose of producing  continuous drug release over a  long period of time. 3-5 mths. 

b.    Anti-pregnancy drugs in  implant form can work for up  to 3 years. C/ (Implanon  contains etonogestrel 68  mg/picture KB) 

c.    The pellets shall not contain  binders, diluents or fillers  intended to allow the complete  dissolution of the absorption  pellets at the planting site. 

d.   Example: estradiol pellets,  usually containing 10 and 25  mg of estrogen estradiol  (typical oral and parenteral  doses of 250 mcg) 

12.     Anticoagulants 

a.    Solution to prevent blood  clotting, conditions such as  injection and free of pyrogens.

b.    Example: ACDP Sterile  Sodium Citrate Solution,  Heparin, ACD 

13.    Vaccine preparation 

a.    It is a biological product  (diagnostic aid) for disease  prevention and treatment  purposes. Anticoagulants 

b.    Solution to prevent blood  clotting, conditions such as  injection and free of pyrogens. 

c.    Example: ACDP Sterile  Sodium Citrate Solution,  Heparin, ACD

 

✔ Based on the physical form of the  product 

1.    Sterile solution 

2.    Sterile suspension 

3.    Sterile emulsion 

4.    Solid serial 

 

 Narasumber

Nama : Nurbaiti Fentiani Siahaan  

NPM : 7120028