Development of an Osmotically Controlled Drug-Delivery System of Glipizide - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Development of an Osmotically Controlled Drug-Delivery System of Glipizide
The authors describe the development of an inclusion complex of GLZ and formulated an extended-release dosage form based on osmotic technology.


Pharmaceutical Technology
pp. 80-91


Table III: Statistical comparison of dissolution profile of inclusion complexes.
Dissolution of pure GLZ and all other prepared systems (i.e., complexes and PMs) were carried out in demineralized water. Table III reports the values for the percent of drug dissolved within 20 min (DP 20min ), mean dissolution time (MDT), and time to dissolve 50% of the drug (t 50% ). The data show that the onset of dissolution of pure GLZ is slow (DP 20min value was 6.14%, and t 50% > 2 h).


Figure 6: Drug-release profile of glipizide–HP–β–CD complexes.
Figure 6 shows dissolution profiles of pure GLZ, its PM, and inclusion complexes with HP–β–CD over a period of 120 min. The dissolution rate of pure GLZ is low; 29.69% of the drug is dissolved in 120 min. Inclusion complexes of GLZ with HP–β–CD significantly enhanced the dissolution rate of GLZ within 120 min, compared with PM and pure GLZ. PM with HP–β–CD also improved GLZ's rate of dissolution. The highest improvement was obtained using a complex prepared through coevaporation.

MDT is the first datum for the cumulative dissolution process that provides an accurate drug-release rate. A high MDT value indicates great drug-retarding ability (18). The MDT of pure GLZ was high (99.64 min). This value decreased greatly after the authors prepared GLZ's inclusion complexes and PM with HP–β–CD, which indicated an increase in dissolution rate. Coevaporation 2:1 had the lowest MDT (12.91 min).

Comparisons between the release profiles of different samples of GLZ were made with similarity factor f 2 . Table III shows that the release profiles of GLZ from all samples (i.e., complexes and PMs of HP–β–CD) and from pure GLZ were dissimilar; f 2 values for these comparisons were less than 50. Coevaporation 2:1, which had a better in vitro dissolution profile, lower MDT, and lower f 2 values, was selected for further formulation of as an EOPT.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
21%
To all process for new products only
11%
To select process for new products only
25%
To select processes for both new and legacy products
21%
Do not use QbD
23%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Source: Pharmaceutical Technology,
Click here