Solutions with thermolabilesubstances. Suspension forinjection.Solutions with thermolabilesubstances. Suspension forinjection.
Author:
ass. Yu.Yu. Plaskonis
Aseptic conditionsAseptic conditions
Aseptic conditions are conditions that ensureprevention of contamination of equipment, facilities,source of raw materials, intermediate products ofviable micro-organisms and mechanical portions toensure the sterility of the ready products. Productionof drugs in aseptic conditions in pharmacies iscarried out in special "clean" rooms, where air purityis standardized for content of microbes andmechanical parts.
Prepared in aseptic conditions, because athigh temperatures they are destruct.
Injection solutions with thermolabilitysubstancesInjection solutions with thermolabilitysubstances
The solvent, filter material and tableware sterilized.The amount of water for injection at a concentrationof drugs more than 3% is calculated taking intoaccount increase factors. Ready solution releasedwith the label «Made aseptically».
List of thermolability substancesList of thermolability substances
barbital sodium,
hexamethylenetetramine,
barbamil,
adrenaline hydrochloride,
apomorphine hydrochloride,
eufilin
etc.
PECULIARITIES OF FORMULATION OFSOLUTIONS FOR INJECTIONS WITHTHERMOLABILE SUBSTANCESPECULIARITIES OF FORMULATION OFSOLUTIONS FOR INJECTIONS WITHTHERMOLABILE SUBSTANCES
they are not sterilized;
they are prepared in aseptic conditions;
all thermalstable ingredients aresterilized;
they are filtered through sterile filters.
FilteredthroughsterilefiltersFilteredthroughsterilefilters
General technologyGeneral technology
As a general rules: prepares solutionof all stable at high temperaturessubstances, sterilizes it, cools andadds termolabile- unstable at hightemperatures substance in asepticconditions.
Rp.: Sol. Hexamethylentetramini 20 %
100 ml
Sterilisa!
D. S. For injections
This medicine is a solution for injections withhexamethylenetetramine, a thermolabilesubstance, in the amount exceeding 3 %.
WCP (reverse side)WCP (reverse side)
CVI hexamethylenetetramine = 0.78
Water for the injections:
100.0 – (20.0 x 0.78) = 84.4 ml
The solution is prepared in asepticconditions, using sterilized water forinjections, filtering material and crockery. Inaseptic conditions pour 84.4 ml of water forinjections into the auxiliary bottle, then add20.0 g of hexamethylenetetramine and mix.Perform the complete chemical analysis,filter the solution into a bottle fordispensing, cork, after that checkparticulate matters and roll with cover. Thenput the number of prescription on the bottleand fill WCP (front side). Stick the labels«For injections» and «Asepticallyprepared».
WCP (front side)WCP (front side)
Date № Pr.
Aquae pro injectionibus sterile 84.4 ml
Hexamethylentetramini 20.0
V = 100 ml
Addita aseptice
Prepared by:(signature)
Checked by:(signature)
Suspension for injectionSuspension for injection
When heated, many of suspensions observedcoarsening of the dispersed phase, which hinderstheir passage through a syringe needle. In thisregard they are prepared in aseptic conditions in asterile mortar from the sterilized ingredients.
Therefore suspension for injections prepare,usually, with sterile powders (if they are stable athigh temperatures), immediately before enteringinto the dosage form (in aseptic conditions)
Way of introduction of suspensions for injection isonly intramuscular.
The difficult technologicalproblem is the choice of thesterilization method, sincesize enlargement of particlesof the disperse phase canoccur in suspensions at ahigh temperature
General technologyGeneral technology
Sterilize separately all components andmixed in aseptic conditions in sterilemortar by the rule of Deryagin. The ready suspension can not besterilized because conglomerates willforme.
After prescription write- Addita aseptice!
Rp.: Streptocidi 6,0
Olei Persicorum 30,0
Sterilisa!
Misce. Da.
Signa. For intramuscularinjection.
In a dry bottle for dispensing filtered30.0 peach oil and sterilized at 180°C30 minutes (at 200 °C - 15 minutesor in an autoclave at 120 °C - 2hours).
In a sterile mortar aseptically grind streptocide6.0 (before sterilized at 150 ° C for 1 hour),first with 30 drops of 95% ethyl alcohol andthen by the rule Deryagin with 3.0 oil to amaximum degree of fineness . Gradually addremaining peach oil. The drug dispense fromthe label "For injection," "Shake before use","Made aseptically”.
WPC (f.s.)WPC (f.s.)
Date № prescription
Streptocidi sterile 6,0
Olei Persicorum sterile 30,0
Addita aseptice
Prepared
Chacked
EMULSIONS FOR PARENTERALNUTRITIONEMULSIONS FOR PARENTERALNUTRITION
Emulsions for parenteral nutrition – arehigh-dispersed heterogeneous systemsrepresented by a medicinal formhomogeneous in appearance consisting ofmutually insoluble liquids.
Positive qualitiesPositive qualities
possibility of solubilize medicinal substanceswith a low solubility in water;
possibility to obtain stable medicines fromcompounds subjected to the hydrolysis in theaqueous medium;
possibility to reduce the irritating or toxiceffect of medicinal substances administeredintravenously;
possibility to obtain medicinal forms with theprolonged action;
possibility to deliver medicinal substancesdirectly to the target organs.
Due to the high caloric value of fat(more than 9 kcal/g), as well as thepresence of carbohydrates in lipidemulsions, their caloric contentexceeds considerably the similarindex of other medicines forparenteral nutrition
SOLUTIONS FOR INJECTIONSBASED ON THE NON-AQUEOUSSOLVENTSSOLUTIONS FOR INJECTIONSBASED ON THE NON-AQUEOUSSOLVENTS
NON-AQUEOUS SOLVENTS have:
different dissolving capability
properties against hydrolysis
bactericidal properties
stabilizing properties
With the help of NON-AQUEOUSSOLVENTS it is possible to obtain:With the help of NON-AQUEOUSSOLVENTS it is possible to obtain:
solutions with a prolonged effect
solutions with a greater shelf life
solutions of substances insoluble andunstable in the aqueous medium
Rp.: Sol. Camphorae oleosae 20 %100.0
Sterilisa!
D. S. For 2 ml subcutaneously
This medicine is an oily solution forhypodermic introduction.
WCP (reverse side)
Camphor20.0
Peach oil 100.0 - 20.0 = 80.0
In aseptic conditions weigh 20.0 g ofcamphor, dissolve in 80.0 g of the warmsterilized oil (peach, almond, olive oil).Then filter in a sterile bottle for dispensingthe heated drying cabinet, close by arubber cap check particulate matters andsterilize the bottle. Perform the control ofparticulate matters. Put the number ofprescription and fill in WCP (front side).Stick the labels «For injections» and«Sterile».
WCP (front side)
Date № Pr.
Camphorae 20.0
Olei Persicorum sterile 80.0
m = 100.0
Sterilis
Prepared by:(signature)
Checked by:(signature)
THANK YOU FOR ATTENTION!THANK YOU FOR ATTENTION!
