FOR Extended Release (ER) Tablet Formulations

An Expert System for Drug Delivery

The need for maintaining dosage regimen, compliance (not to miss the dose) and desired therapeutic response has been a much sought after approach in drug delivery systems. Single and immediate release dosage administration at defined frequency has been practiced from times immemorial. With the study and evaluation of PK, PD and ADME profiles of drug substances, the approach for designing dosage forms has assumed new dimensions. The terms Modified Release, Sustained Release, Prolonged Release, Extended Release etc. have become very common.

The challenge has been to produce cost effective, reproducible and therapeutically effective and reliable dosage systems. Amongst a host of technologies available today the Matrix system (using polymers) is the most accepted and easy to adopt.

Ideal Cures realized the need for ready-to-use ER formulations which could be processed with specific drug substances resulting in satisfactory, reproducible dosage forms meeting the requirements of in-vitro and in-vivo drug release profiles. The objectives were to develop a system that reduces process time, offers process economies and is cost effective whilst having all the attributes that assure the desired therapeutic response.

Time and speed being most crucial for product launch, offering such systems, particularly to companies with limited development resources, provides a significant advantage.

With a background and technical expertise in polymers and dosage form design, Ideal Cures has been well positioned to developed an expert system called ‘Instamodel’ Extended Release System based on predictive modelling for HPMC matrix tablets.

Concept Of Instamodel Extended Release System

The success of HPMC matrix tablet formulation depends upon the correct selection of polymers, release regulators and other diluents, their ratios and tablet geometry. INSTAMODEL blends are drug molecule specific taking into consideration compatibilities, stability and comparative profiling with the brand leader or International Brands (RLD). Attention is also given to trade dress, IIG limits and the GRAS nature of the excipients used.

1. Instamodel Blend

This is a proprietary, optimized blend of polymers, release modifiers and tablet diluents. The start-up formula is generated by the INSTAMODEL predictive modeling system and actual experiments with drug substances, ensuring scalability and manufacturing feasibility. The formulator is only required to add the drug and process the product as per guidelines provided, to manufacture compliant products.

2. Instamodel ER Products

Customers have access to our facilities to perform trials and satisfy themselves before planning their product application. Ideal Cures will also assist them to ensure feasibility in their own manufacturing set-up so that reproducibility and compliance can be assured.

Salient Features of Instamodel Service

  • Designed to provide starting formulations to customers for hydrophilic matrix systems
  • Increases speed to market
  • Improves efficiency and productivity
  • Reduces number of trials required to reach the final formulation
  • Backed by strong technical support from Ideal Cures

Application Examples of Instamodel Service

  • Metformin Hydrochloride ER Tablets 500, 750, 800 and 1000 mg
  • Metoprolol Succinate ER Tablets 25, 50, 100 and 200 mg
  • Trimetazidine 35 mg ER Tablets
  • Gliclazide ER Tablets
  • Diclofenac and Aceclofenac ER Tablets
  • Acetaminophen PR Tablets
  • Carbamazepine 200 mg ER Tablets

Requests for development of systems with other drugs substances can be accepted based on customer needs and market requirements.