Barium Sulfate Suspension
Radiological imaging of the digestive tract can only be achieved if it is coated with a high-density material. For this purpose, the use of a contrast agent is necessary. Contrast agents (radiopaques) are used to provide information about the body structure by increasing the absorption of X-rays passing through the body. The selection of the contrast medium to be used must meet important criteria. The most crucial of these features is having no toxic effect on the patient. In accordance with the required properties, barium solutions are used. Barium preparations leave the body via the intestinal tract without being absorbed in the digestive canal, providing the desired contrast in radiological examinations. In addition, its affordability is another reason for preference. Although ease of ingestion is required especially when taken orally, it can be difficult for some patients to tolerate. For this reason, low-viscosity preparations should be used.
It is used in the radiological examination of the gastroduodenal system. It is contraindicated in suspected intestinal obstruction or perforation, and in pyloric stenosis. It must not be used in patients with known hypersensitivity to barium sulfate or to any of the substances contained in the suspension. Administration of barium sulfate as an enema requires great caution, especially in patients with intestinal disease, children, the elderly, and debilitated individuals.
Adequate fluid intake should be ensured following the procedure to prevent constipation. Shake well before use. Its use is not recommended during pregnancy because radiological examinations are inadvisable. In nursing mothers, it is recommended to take the medication under medical supervision. Since barium sulfate is not absorbed from the stomach and intestines, it has no effect on the ability to drive and use machines. When administered rectally, it may rarely cause colonic dilatation and constipation. Unless otherwise advised by a physician; the well-shaken suspension is administered to the patient for ingestion, and imaging is initiated. Radiobarite suspension may also be used as an enema. It should be stored at room temperature below 25°C and strictly protected from freezing.
Rp.
Barium sulfate 23 g
Polyvinylpyrrolidone (PVP) 1 g
Sodium carboxymethylcellulose 0.092 g
Methylparaben 100 mg
Propylparaben 20 mg
Sodium bisulfite 70 mg
Distilled water q.s. 100 ml
Substances in the formula:
Barium sulfate – Barii sulfas – Barium sulfate – Sulfate de baryum:
Barium sulfate is a radiopaque agent administered orally and rectally. It is used as a contrast medium in radiographic examinations of the gastrointestinal tract. It can also be used in the detection and evaluation of abnormalities in the esophagus and colon. Radiographic contrast media (radiopaque agents) increase the absorption of X-rays passing through the body, thereby allowing distinct delineation of body structures. This explains the use of barium sulfate as a contrast medium. Barium sulfate is a fine, heavy, white, and odorless powder free of gritty particles. It is practically insoluble in water and organic solvents; very slightly soluble or practically insoluble in acids and alkali hydroxides.
Barium sulfate must not contain chloride or carbonate in its composition. If it contains carbonate, it converts to chloride in the stomach and exhibits toxic effects. The lethal dose for the chloride is 0.9 g. Death occurs within 6 to 12 hours. In case of poisoning, gastric lavage is performed with a magnesium sulfate solution, and the patient is kept warm.
Gastrointestinal radiography:
As a contrast agent in upper gastrointestinal tract examinations:
Adults: 75–2400 ml PO of a 40–250% w/v suspension. The volume is determined according to the specific examination to be performed.
Children: The oral volume to be administered from a 50–250% w/v suspension is determined by the physician based on the specific examination to be performed.
As a contrast agent in lower gastrointestinal tract examinations:
Adults: 0.350–2.5 liters of a 17–125% w/v suspension administered rectally; the volume is determined depending on the specific examination to be performed.
Children: 15–120% w/v suspension given via the rectal route. The amount to be administered is determined by the physician according to the specific examination to be performed. The safe use of barium during pregnancy has not been established; in pregnant women, it should only be used if the potential benefit justifies the potential risk to the fetus. Radiopaque agents are typically classified as Category X. The use of barium sulfate in elective radiography of the abdominal region following barium administration is contraindicated due to fetal radiation exposure; in utero radiation exposure is known to be harmful to the fetus.
Polyvinylpyrrolidone (PVP) – Polyvidone – Poly(1-vinyl-2-pyrrolidinon) [IUPAC; ASK]- Polyvidonum [PhBs IV; Ph. Eur. 3; Ph. Int. III]- Povidonum [Ph. Eur. 3]:
Polyvinylpyrrolidone (PVP) is a synthetic polymer mixture used for various purposes. Its composition is very similar to natural tears. In addition, types of PVP with an average molecular weight ranging between 10,000–70,000 are used as dispersing and suspending agents in pharmacy; those with a molecular weight between 20,000–40,000 were formerly used as plasma volume expanders. Povidone (PVP) is a mixture of linear synthetic polymers of 1-vinylpyrrolidin-2-one with different molecular lengths and weights. It occurs as a hygroscopic powder or flakes, white or yellowish-white in color, with a faint odor. It is freely soluble in water, alcohol, and chloroform; practically insoluble in ether. The pH of its 5% aqueous solution is between 3 and 7.
Sodium carboxymethylcellulose – Carboxymethylcellulose sodium – Carboxyméthylcellulose sodique [DCF; FP]- Carboxyméthylcellulose sodique [DCF; FP]:
Sodium carboxymethylcellulose is used in conditions such as dry eye syndrome (keratitis sicca) or keratoconjunctivitis sicca, where ocular surface hydration is impaired due to deficient or structurally abnormal tear film layers. Like all artificial tear products, it exerts its effect mechanically rather than pharmacologically. Sodium carboxymethylcellulose is also used as an excipient in the preparation of pharmaceutical formulations. Sodium carboxymethylcellulose is a white, odorless, granular powder. It is practically insoluble in acetone, alcohol, ether, and toluene. It disperses in water to yield a clear colloidal solution. It is reported to be incompatible with strong acid solutions, soluble iron salts, certain other metals such as aluminum, mercury, and zinc, and xanthan gum.
Methylparaben – Methyl parahydroxybenzoate – Methyl hydroxybenzoate – Nipagin M:
Methylparaben is widely used as an antimicrobial preservative in pharmaceutical formulations, cosmetic products, and foods. It is used alone or in combination with other parabens or other antimicrobial agents. It is the most commonly used preservative, particularly in cosmetic products. In the presence of nonionic surfactants, its antimicrobial activity decreases significantly. The estimated acceptable daily maximum intake for methyl, ethyl, and propylparaben is reported as 10 mg per kg of body weight. Methylparaben occurs as colorless crystals or a white crystalline powder, odorless or with a faint characteristic odor. It is freely soluble in ethanol, methanol, ether, and propylene glycol; sparingly soluble in water; practically insoluble in liquid paraffin.
Propylparaben – Propyl parahydroxybenzoate – Propylis parahydroxybenzoas – Nipasol M:
Propylparaben is an antimicrobial preservative. It is widely used as a preservative in pharmaceutical formulations, cosmetic products, and foods. It is used alone or in combination with other parabens or other antimicrobial agents. It stands as the second most frequently used preservative, particularly in cosmetics. In the presence of nonionic surfactants, its antimicrobial activity is considerably weakened. The estimated acceptable daily maximum intake for methyl, ethyl, and propylparaben is reported as 10 mg per kg of body weight. Propylparaben is a white, odorless, crystalline powder with no distinct taste. It is very slightly soluble in water; freely soluble in ethanol, methyl alcohol, propylene glycol, acetone, and diethyl ether.
Sodium bisulfite – Sodium hydrogen sulfite – Sodium bisulphite – Hydrogen sulfite sodium:
Sodium bisulfite is used as an antioxidant in pharmaceutical formulations at a concentration of 0.01–1%. Sulfites may cause hypersensitivity reactions, including bronchospasm and anaphylaxis. At high doses, they can cause gastrointestinal disorders, respiratory, circulatory, and central nervous system disturbances. Sodium bisulfite is a white crystalline powder. It dissolves in water at 1:3.5 at 20°C, 1:2 at 100°C, and in ethanol (95%) at 1:70. It must be stored in tightly closed, airtight containers. Sulfites react with sympathomimetic drugs and ortho- and para-hydroxybenzyl alcohol derivatives. As a result, sulfonic acid derivatives with little or no pharmacological activity are formed. Adrenaline and its derivatives are among the most important drugs subject to this inactivation.
Distilled water – Purified water – Aqua [INCI-EU]- Gereinigtes Wasser [ASK]- Water, purified [BP; NF; USP]- Wasser, gereinigtes [Ph.Eur.]:
Distilled water is high-purity water prepared by the distillation of potable water and used as a solvent or vehicle in numerous pharmaceutical formulations. It is a clear and colorless liquid with no characteristic odor or taste. In pharmacy, whenever water is mentioned, distilled water should be understood. The shelf life of distilled water is limited. In any case, it must be boiled prior to use. Because additional specific properties are required for water used in parenteral preparations, water for injection must be used for that purpose. Additionally, since it is less expensive and easier to obtain, deionized water may also be used in place of distilled water in pharmaceutical preparations where its use is permitted.
Preparation of the Formula:
The total quantity of this preparation is 100 mL. Based on these values, considering the proportion of each ingredient in the prescription, the preparation can be prepared in amounts lesser or greater than 100 mL.
70 mL of distilled water is heated, and methylparaben, propylparaben, and sodium bisulfite are dissolved in it.
PVP and sodium carboxymethylcellulose are added to this prepared solution and mixed until a homogeneous mixture is obtained.
To this mixture, barium sulfate, which constitutes the dispersed powder mass in this suspension, is added.
It is stirred until homogeneous and made up to 100 mL with water. Using a mechanical stirrer at 2000 rpm during the mixing process will enhance the quality and homogeneity of the preparation. Pharma-grade barium sulfate must strictly be used in the preparation of the formula. 02.01.2022
References:
1-RxMediaPharma® Interactive Drug Information Resource 2022
2-TEB Compounding Pharmacy Guide (TEB Majistral İlaç Rehberi)
3-Medical Formulas 11th Edition / Cemal Kasım Güven
