Recipe: Glucosi                                    0.2

             Osarsoli                                  0.1

            Streptocidi                             0.3

           Basis gelatino cum glycerino quantum satis ut fiant

           Suppositoria vaginalia

           Da tales doses № 10

           Misce. Da. Signa. By 1 suppository 2 times a day vaginally

 

The prescribed dosage form is solid (to the touch) at room temperature, dissolving at body temperature, specific dosage form - vaginal suppositories.

 

The prescription contains a substance from List A, but we do not check the doses, since the dosage form is for external use.

 

Properties of substances:

Glucose

Glucosum – colorless crystals or white microcrystalline powder, odorless, sweet taste. Soluble in 1.5 parts of water, poorly soluble in 95% alcohol, practically insoluble in ether.

 

Osarsol

Osarsolum is a white, odorless crystalline powder. It is very slightly soluble in water and alcohol, soluble in solutions of sodium bicarbonate, caustic alkalis and ammonia.

 

Streptocide

Streptocidum is a white, odorless crystalline powder. It is slightly soluble in water, readily soluble in boiling water, diluted hydrochloric acid, caustic alkali solutions, and acetone, sparingly soluble in alcohol, and practically insoluble in ether and chloroform.

 

Gelatin -

Gelatina is a product of partial hydrolysis of collagen. Colorless or slightly yellowish translucent flexible leaflets or small plates without odor. Practically insoluble in cold water, but swells and softens, gradually absorbing water from 6 to 10 parts of its own weight. Soluble after swelling in hot water, acetic acid and a hot mixture of glycerin and water, practically insoluble in alcohol, ether and chloroform.

 

Glycerol-

Glycerinum is a colorless, transparent liquid with a sweet taste, miscible with water in all proportions.

 

According to the recipe, suppositories are made on a hydrophilic base, therefore suppositories are prepared by pouring. The size and shape of the cells in the mold may be different. When making suppositories by pouring, it is necessary to take into account the substitution coefficient of medicinal substances, since the volumes occupied by the base and substances are different. If the medicinal substances are more than 5%, then it is necessary to take into account the substitution coefficient. The weight of 1 vaginal suppository according to the State Pharmacopoeia XI should be at least 4.0 grams.

 

Calculations:

In total, glucose 0.2 + Osarsol 0.1 + Streptocide 0.3 = 0.6

0.6-4.0

X—100.0 X=15%, we take into account the replacement (substitution)  coefficient.

 

 

Glucose:       0.2x10=2.0                          E= 1,23

 

1,23----------1,0

2,0--------------X             X= 1,62

 

 

Osarsol         0.1x10=1.0                          E= 1,45

 

1,45--------------1,0 g of fat base

1,0-----------------X                                X= 0,69

 

 

 

Streptocide   0.3x10=3.0                          E=2.0

 

2,0 ---------------1,0 of fat base

3,0 -----------------X                                             X = 1,5

 

 

 

Suppository mass 4.0x10=40.0

Bases 40.0 - (1,62 + 0.69 + 1.5) = 36.19

These are fat bases with a density of 0.95.

 

 

Transition to a gelatin-glycerin base, which has a different density:

 

0.95 –35.19

1.15 - X X = 43.80

Base composition: gelatin 1 part

Water 2 parts

Glycerin 5 parts.

Calculation: gelatin 43.80:8= 5.47

Water 10.94

Glycerin 27.39

 

Technology:

Weigh out 5.47 g of gelatin, pour in 10.94 ml of cold water and leave to swell for 30-40 minutes. Then add 27.39 glycerin and heat in a water bath with constant stirring until the gelatin is completely dissolved.

Glucose is very easily soluble in water, we put it into the prepared base, it will dissolve when stirred with a stick.

Osarsol and streptocide are not soluble, they are introduced as a suspension. We weigh out streptocide in a mortar, grind, weigh out osarsol under the supervision of a pharmacist-technologist responsible for dispensing toxic substances and place in a mortar. First, add a small amount of the base, grind, then the rest. The mortar must be preheated to prevent the mass from solidifying. Then grease the molds with vaseline oil and pour the mass into the cells. The mass in the molds solidifies in the refrigerator. After solidification, take out the suppositories, wrap each in a wax capsule and place in a paper bag. We issue for dispensing, label "External". "Store in a cool place." The shelf life is 10 days.

 

PWC Date No. Rec. Gelatina 5.47 Aqua purificata 10.94 Glycerin 27.39 Glucosum 2.0 Streptocidum 3.0 Osarsolum 1.0   M total 49.80 M 1=4.98 N 10 Prepared Checked

The other side of the PPK Calculations: In total, glucose 0.2 + Osarsol 0.1 + Streptocide 0.3 = 0.6 0.6-4.0 X—100.0 X=15%, we take into account the replacement (substitution)  coefficient.   Glucose:       0.2x10=2.0                          E= 1,23   1,23----------1,0 2,0--------------X             X= 1,62   Osarsol         0.1x10=1.0                          E= 1,45   1,45--------------1,0 g of fat base 1,0-----------------X                                X= 0,69   Streptocide   0.3x10=3.0                          E=2.0   2,0 ---------------1,0 of fat base 3,0 -----------------X                                             X = 1,5     Suppository mass 4.0x10=40.0 Bases 40.0 - (1,62 + 0.69 + 1.5) = 36.19 These are fat bases with a density of 0.95.   Transition to a gelatin-glycerin base, which has a different density:   0.95 –35.19      1.15 - X                       X = 43.80 Base composition: gelatin 1 part Water 2 parts Glycerin 5 parts. Calculation: gelatin 43.80:8= 5.47 Water 10.94 Glycerin 27.39