Product image of Klean-Prep (Sodium Hydrogen Carbonate, Potassium Chloride, Sodium Chloride, Sodium Sulfate Anhydrous, Macrogol 3) supplied by GNH India

Klean-Prep

Active Ingredient:
Sodium Hydrogen Carbonate, Potassium Chloride, Sodium Chloride, Sodium Sulfate Anhydrous, Macrogol 3
Origin:
EU

Klean-Prep (Sodium Hydrogen Carbonate, Potassium Chloride, Sodium Chloride, Sodium Sulfate Anhydrous, Macrogol 3)

Sodium Hydrogen Carbonate, the primary ingredient in Klean-Prep, is an excipient presented as an oral powder for oral use. It is combined with potassium chloride, sodium chloride, sodium sulfate anhydrous and macrogol 3 to form a multifunctional excipient blend used in pharmaceutical manufacturing. Klean-Prep does not have therapeutic activity on its own but supports formulation stability, osmolarity and tablet integrity.

GNH India supplies Klean-Prep as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Norgine Limited

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Indications & Clinical Uses

Klean-Prep is employed as an excipient in oral pharmaceutical formulations, providing buffering, osmotic balance and tablet matrix support.

  • Buffering: stabilises pH in oral solutions and suspensions.
  • Osmotic balance: adjusts ionic strength to improve drug solubility.
  • Tablet filler: contributes to tablet weight, hardness and disintegration profile.

How It Works

  • Klean-Prep functions as a multifunctional excipient blend. Sodium hydrogen carbonate and sodium chloride act as buffering agents that maintain solution pH, while potassium chloride and sodium sulfate provide ionic strength and osmotic balance. Macrogol 3 serves as a hydrophilic polymer that enhances wetting, improves tablet compressibility and aids in controlled release. Together, these components facilitate manufacturing processes and ensure consistent drug product performance without exerting pharmacological effects.

Side Effects

Klean-Prep may cause mild, formulation‑related reactions when administered orally.

Common Side Effects

  • Nausea: transient feeling of stomach upset.
  • Mild abdominal discomfort: occasional cramping or bloating.
  • Diarrhoea: loose stools that resolve spontaneously.
  • Electrolyte shift: slight changes in serum sodium or potassium levels.
  • Taste alteration: temporary metallic or salty taste.
  • Headache: mild, short‑lasting headache.

Serious or Rare Side Effects

  • Hypersensitivity reaction: rash, itching or swelling.
  • Anaphylaxis: severe, rapid allergic response requiring emergency care.
  • Severe electrolyte disturbance: significant hyper‑ or hyponatraemia.
  • Persistent vomiting: prolonged emesis leading to dehydration.
  • Acute renal impairment: sudden decline in kidney function in susceptible individuals.

Precautions & Warnings

When using Klean-Prep, consider the following safety measures.

  • Assess electrolyte status: evaluate baseline sodium, potassium and chloride levels before administration.
  • Monitor gastrointestinal tolerance: watch for persistent nausea or diarrhoea.
  • Avoid in known hypersensitivity: do not use in patients with documented allergy to any component.
  • Use with caution in renal impairment: adjust formulation use in patients with reduced kidney function.
  • Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Klean-Prep can influence the performance of other orally administered agents.

Major Interactions (Avoid)

  • High‑dose electrolyte supplements: may cause dangerous electrolyte overload.
  • Drugs requiring strict pH control (e.g., certain antacids): buffering action can alter drug stability.

Moderate Interactions (Monitor Closely)

  • Antacids: concurrent use may modify gastric pH and affect absorption.
  • Certain antibiotics (e.g., tetracyclines): ionic strength may reduce bioavailability.
  • Liquid formulations containing calcium: risk of precipitation or reduced solubility.
  • Controlled‑release products: excipient may affect release kinetics.
  • Nutritional supplements with high sodium content: monitor total sodium intake.

Frequently Asked Questions

Klean-Prep is an excipient blend used in the manufacture of oral pharmaceutical products. It provides buffering capacity, osmotic balance and tablet‑filling properties, helping to stabilise the formulation, improve drug solubility and ensure consistent tablet hardness and disintegration.

Sodium hydrogen carbonate acts as a buffering agent that maintains the pH of oral solutions within a desired range. By neutralising excess acidity or alkalinity, it helps preserve the chemical stability of the active drug and supports optimal absorption characteristics.

The amount of Klean-Prep incorporated into a formulation is determined by the prescriber or formulation scientist based on the specific product requirements. Dosage is not set for patients, as Klean-Prep is an inactive ingredient used only during manufacturing.

Klean-Prep is an excipient and does not have therapeutic activity. However, because it contains sodium and potassium salts, it should be used with caution in pregnant or breastfeeding individuals only if the overall formulation has been evaluated for safety by the prescribing physician.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Klean-Prep combines multiple inorganic salts and a polymer (macrogol 3) in a single blend, offering simultaneous buffering, ionic strength adjustment and tablet‑filling functions. Compared with single‑component excipients, it can reduce the number of additives required, simplifying formulation development while maintaining performance.

Store Klean-Prep at room temperature, preferably below 25 °C. Keep the product in its original container, protect it from moisture and direct sunlight, and avoid contamination by using clean, dry equipment during handling.

Klean-Prep is not administered directly to patients. It is incorporated into oral dosage forms such as tablets, capsules or liquid suspensions during the manufacturing process, where it functions as an inactive supporting ingredient.

The most serious risks involve hypersensitivity reactions, including rash, itching, swelling or anaphylaxis, and severe electrolyte disturbances that could lead to hyper‑ or hyponatraemia, especially in patients with compromised renal function or those receiving large amounts of electrolytes.

Patients with known allergy to any of the component salts or macrogol 3, individuals with severe renal impairment, and those on high‑dose electrolyte therapy should avoid products containing Klean-Prep unless a healthcare professional determines it is safe.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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