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Ofloxacin + Ornidazole Suspension

Manufacturing Process of Ofloxacin + Ornidazole Suspension (50mg + 125mg/5ml) by Den Mark Pharmaceuticals Pvt. Ltd.

Recent research has shown that concurrent use of an antibiotic Ofloxacin + Ornidazole Suspension results in greater symptom relief as opposed to a slight improvement in infections with each treatment.

This content outlines the manufacturing process for Ofloxacin + Ornidazole Suspension (50mg Ofloxacin + 125mg Ornidazole per 5ml) for Den Mark Pharmaceuticals Pvt. Ltd., following WHO GMP guidelines.

Process Steps

Weighing and Pre-mixing:

  • In a designated weighing area, qualified personnel weighs precisely measured quantities of Ofloxacin API and Ornidazole API according to the approved production batch formula.
  • Each API will be pre-mixed with a portion of purified water using a suitable blender to ensure proper dispersion.

Preparation of Primary Suspension:

  • The pre-mixed APIs will be combined with the remaining purified water in a jacketed mixing vessel.
  • The suspending agent will be gradually added under constant mixing to achieve a uniform consistency.

Homogenization:

  • The primary suspension will be passed through a homogenizer to create a uniform particle size distribution and enhance stability.

Maturation:

  • The complete suspension will be allowed to mature in a closed vessel for a predetermined time to agent for complete hydration of the suspending agent and to ensure optimal stability.

Filling and Capping:

  • An automated filling line will fill The matured suspension into pre-sterilized bottles.
  • The bottles will be immediately sealed with pre-sterilized caps under aseptic consent.

Labelling and Packaging:

  • Labels containing product information, dosage instructions, expiry date, and batch number will be applied to each bottle.
  • Labeled bottles will be placed in cartons and sealed for secondary packaging.

Quality Control:

Throughout the process, samples of Ofloxacin + Ornidazole Suspension will be collected for various quality control tests, including:

  • Weight of API per unit dose
  • Appearance and viscosity
  • Assay (concentration of Ofloxacin and Ornidazole)
  • Dissolution profile
  • Microbiological testing for sterility
  • Container closure integrity testing

Documentation and Batch Release:

  • All production activities will be documented according to SOPs (Standard Operating Procedures).
  • A qualified person will review and approve batch records before product release.

Storage and Distribution:

  • The finished Ofloxacin + Ornidazole Suspension will be stored under recommended conditions (e.g., temperature, light) until distribution.
  • Distribution will be carried out using a qualified cold chain system (if required).

Additional Considerations:

  • All personnel involved in the manufacturing process must be trained in GMP principles.
  • The manufacturing area must be maintained clean and hygienic.
  • Appropriate validation studies should be conducted to ensure the process consistently produces a high-quality product.

Following these rules, Patients can receive high-quality, safe, and effective ofloxacin + Ornidazole Suspension by Den Mark Pharmaceuticals Pvt. Ltd., a reputed Pharmaceutical Manufacturing company.