World Class

Quality

Puji Rahayu, Pharm.

Makasar, April 6th 2013

by PT Ferron Par Pharmaceuticals

Once daily metformin

Factory site cGMP certification by UK-MHRA,

TGA and German Health Authority

European grade raw materials

European formulation standard

Quality by Design

Bioequivalent to originator

Marketed in European Union as GLUCIENT SR

World Class

Quality

World Class

Quality

From the first Indonesian pharmaceutical

company certified by UK-MHRA, TGA and
Germany Health Authority:
PT FERRON PAR PHARMACEUTICALS
Innovation, Quality, and Care

Congratulations for PT. Ferron Par Pharmaceuticals!

Approval CPOB dari BPOM

Sertifikat ISO 9001:2000
Memenuhi standar cGMP

Ferron goes to UK 21 July 2008

World Class

Quality

World Class

Quality

Drug Delivery Technologies:

Once daily METFORMIN
Extended Release caplet

Modified-release drugs
Oral drug delivery the most widely utilized
route of administration
Most of the pharmaceutical scientists are
involved in developing an ideal DDS (Drug
Delivery System)
Major goal set in designing sustained or
controlled delivery is to:
Reduce the frequency of dosing
Increase effectiveness of the of the drug by
localization at the site action
Reducing the dose required
Providing the uniform drug delivery

Extended-Release Drugs

Pharmaceutical dosage forms that release the drug slower

than normal manner at predetermined rate & necessarily
reduce the dosage frequency by two folds

Extended Release (XR) = Sustained Release (SR)

Reduces the see-saw fluctuation

Extended-Release Drugs
Criteria to be met by drug proposed to be formulated in sustainedrelease dosage forms:
CRITERIA

METFORMIN HCl

Desirable half-life
2 < t < 8 hours

5-6 hours

High therapeutic index

high

Small dose

500-2000 mg/day

Desirable absorption and solubility

characteristic
Soluble in water

Freely soluble in water as HCl salt

Desirable absorption window

Could be absorbed from the whole

intestine

First pass clearance

Does not undergo extensive hepatic firstpass metabolism

Does not undergo hepatic metabolism

(not significant)

http://www.drugbank.ca/drugs/DB00331; http://www.fda.gov/ohrms/dockets/dailys/02/May02/053102/800471e6.pdf

Extended-Release Drugs

Sustained (zero-order) drug release has been attempted to be

achieved by following classes of sustained drug delivery system:
A) Diffusion sustained system.
Reservoir type
Matrix type
B) Dissolution sustained system.
Reservoir type
Matrix type
C) Methods using Ion-exchange.
D) Methods using osmotic pressure.
E) pH independent formulations.
F) Altered density formulations.

The technology of

Extended Release with

diffusion sustained by
hydrophilic matrix system

Uses polymer as matrix

materials.
Ex. : HPMC, HMC, polyethylene
oxide, natural gums, etc.

Upon immersion in water the

hydrophilic matrix quickly
forms a gel layer around the
tablet. Drug release is sustained
by a gel diffusional barrier.

A solid drug is dispersed in an insoluble

matrix and the rate of release of drug is
dependent on the rate of drug diffusion.

Hydrophilic Matrix System

Exposure of drug to GI fluid

GI fluid enters the matrix system

The polymers become hydrated and

swollen. The hydrophilic matrix quickly
forms a gel layer around the tablet

API (metformin) released in a

slow manner

World Class

Quality

The pharmaceutical technology

advantages in increasing
efficacy, safety profile and
patient compliance

Efficacy of conventional metformin (IR) vs

metformin XR

Patients T2DM who had been receiving twice-daily MIR achieved comparable
glycemic control when therapy was switched to once-daily MXR at the same or
a greater total daily dose. A greater HbA1c reduction was achieved
using metformin XR 1000 mg (once daily) compared to metformin IR
500 mg twice a day in 24 weeks of treatment
Clin Ther 2003;25:515-29

Safety profile of conventional metformin

(IR) vs metformin XR

-55%
-54%

Patients switched from immediate-release metformin to metformin-XR

experienced fewer GI side effects on comparable doses of the
extended release metformin.
Curr Med Res Opin 2004;20(4):565-72

Influence of oral antidiabetic drugs compliance on

metabolic control in type 2 diabetes. A survey in
general practice

Reducing daily dosing frequency of oral

antidiabetic agents improves compliance with
treatment and metabolic control
Guillausseau, Diabetes Metab 2003; 29(1): 79-81.

by PT Ferron Par Pharmaceuticals

Once daily metformin

Factory site cGMP certification by UK-MHRA,

TGA and German Health Authority

European grade raw materials

European formulation standard

Quality by Design

Bioequivalent to originator

Marketed in European Union as GLUCIENT SR

World Class

Quality

500

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