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Formulation and evaluation of controlled-release matrix systems of ciprofloxacin
Venkata Ramana Malipeddi1, Rajendra Awasthi2, Kamal Dua3
1Amity Institute of Pharmacy, Amity University, Lucknow, India.
Background:
Ciprofloxacin is a broad-spectrum fluoroquinolone antibacterial drug to which most Gram-negative and many Gram-positive bacteria are highly susceptible. Fluoroquinolones are administered repeatedly, twice a day for 5 days, during the course of therapy. Hence, they require repeated administration. Ciprofloxacin qualifies as a drug candidate for a controlled-release drug delivery system.
Objectives:
The present work was aimed to develop ciprofloxacin hydrochloride-containing matrix tablets by the wet granulation method.
Material And Methods:
The tablets were prepared using EthocelTM 100 Premium and Eudragit® RS PO (Evonik Laboratory, Mumbai, India) as a rate-controlling polymer. Granular dioctyl phthalate (DCP) was used as a diluent. An isopropyl alcohol and dichloromethane (1:1) mixture was used as a granulating agent. The effect of the formulation variables on tablet performance was examined based on weight variation, hardness, friability, thickness, and drug release profiles. The results suggested that the tablets had good integrity.
Results:
The tablets were stable for 18 months. Formulation F7 gave a linear release pattern up to 12 h. The release of ciprofloxacin from formulation F7 followed zero-order kinetics. The release mechanism was found to be diffusion-controlled as the Higuchi equation was obeyed.
Conclusions:
Ciprofloxacin hydrochloride-containing matrix tablets were prepared successfully. The tablets had good integrity and were found stable for 18 months.
Insights
Controlled-release ciprofloxacin hydrochloride matrix tablets were successfully developed using wet granulation. These stable tablets offer a 12-hour zero-order drug release, ideal for improved antibacterial therapy.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic requiring frequent dosing.
- Its administration profile makes it a suitable candidate for controlled-release formulations.
- Developing such systems can enhance therapeutic efficacy and patient compliance.
Purpose of the Study:
- To develop ciprofloxacin hydrochloride-containing matrix tablets.
- To utilize wet granulation for tablet preparation.
- To investigate controlled-release properties of the developed tablets.
Main Methods:
- Matrix tablets formulated using Ethocel™ 100 Premium and Eudragit® RS PO as rate-controlling polymers.
- Granular dioctyl phthalate (DCP) served as a diluent.
- Isopropyl alcohol and dichloromethane mixture used as a granulating agent.
- Tablet performance evaluated via weight variation, hardness, friability, thickness, and drug release.
Main Results:
- Formulation F7 exhibited a linear drug release profile for up to 12 hours.
- Ciprofloxacin release from formulation F7 followed zero-order kinetics.
- The release mechanism was confirmed to be diffusion-controlled, adhering to the Higuchi equation.
- Tablets demonstrated good integrity and stability for 18 months.
Conclusions:
- Successful development of ciprofloxacin hydrochloride matrix tablets.
- The developed tablets possess good integrity and long-term stability.
- The formulation provides a controlled release of ciprofloxacin, potentially improving treatment regimens.
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