The API used for manufacture of Lansoprazole is synthesized using a non-infringing route. The use of non-infringing excipients and aqueous coatings makes it aptly suitable for the regulatory market. The quality of the pellets is based on the in-vitro time & release dissolution profile besides the assay and the impurity profile.
Dissolution studies have also been conducted at various intestinal pH ranges. The dissolution values a direct measure of the coating efficiency and also reflects on the molecules in-vivo behavior hence optimum therapeutic efficacy is assured.
The semi-finished dosage form is available in the same strengths as Omeprazole and is intended for use in capsule as well as in suspension. The micro-pellets can be employed for manufacturing tablets.