A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 17th Year of Publication
Page 1 of 2

Materials

EFFECT OF DEGRADATION PRODUCTS FROM BIODEGRADABLE POLYMERS
USED AS IMPLANT MATERIAL IN BIO-SYSTEM

 

Dr. Subhas C.Shit
Deputy Director,
CIPET – Ahmedabad

Abstract

Biodegradable polymers are degraded in the biologically assisted degradation process. They offer many advantages over other materials because of their bio absorbable and resorbable nature in biological systems. In spite of their such advantages they are drawing lot of criticism since their degradation products are not always free from effects which are responsible for many biological disorder. Just for example, some types of polymers have been extensively used in surgical application for last few decades as suture materials. But they have been found to cause problems since they were typically made from a single polymer system. They either degrade too quickly and reacts with tissues or take long time to degrade and thus offer no advantages over other conventional material like metal. Therefore, in order to avoid such problem necessity of making tailored polymer structure is recently felt.

INTRODUCTION

The most common bio-degradable polymers previously used in orthopedics were created from L lactide, D lactide and glycolide, L lactide, D lactide Glycolide and Tri-methylene carbonate (TMC) are based on single monomer units (Fig.1)

Fig. 1 Monomer Units

They found to cause problem when used as implant materials. The degradation of PLA and PGA generally involves random hydrolysis of their ester bonds. PLA degrades to form lactic acid which is normally present in the body. This acid then enter tri carboxylic acid and excreted as water and carbon dioxide. No significant amount of accumulation or degradation product on PLA have been reported in any of the vital organs, but the degradation rate depends on manufacturers configurational structure, co polymer ratio, crystallinity, molecular weight, morphology, stresses, amount or residual monomer, porosity and site of implantation.

Carbon (C13) labelled PLA has demonstrated little radioactivity in feces or urine indicating that most of the degradation products are released through respiration. Concerns about the biocompatibility of these materials have been raised when PLA produced toxic solutions probably as a result of acidic degradation. Another concern is the release of small particles during degradation which can trigger an inflammatory response.

Poly (glycolic acid) (PGA) is a rigid thermoplastic materials with high crystallinity (46-50%) The glass transition temperatures of PGA are 36 and 2250C. Because of high crystallinity PGA is not soluble in most organic solvent, the exceptions are highly fluorinated organic solvents such as hexefluoro isopropanol.

Although common processing techniques such as extrusion, injection and compression moulding can be used to fabricate PGA into various forms, its high sensitivity to hydrolytic degradation requires careful control of processing conditions. Porous scaffolds and foams can be also fabricated from PGA, but the properties and degradation characteristics are affected by the type of processing technique. Solvent casting, particular bleaching method and compression moulding are also used to fabricate PGA based implants.

The preferred method for preparing high molecular weight PGA is ring opening polymerization of glycolide, the cyclic dimmer of glycolic acid and both solution and melt polymerization can be used. Although it is possible to synthesis these polymers by acid catalysed polycondonsation of respective acids, the resulting polymers generally have a low molecular weight and often poor mechanical properties. The attractiveness of PGA as a biodegradable polymer in medical application is that its degradation product glycolic acid is a natural metabolite. A major application of PGA is in resorbable sutures.

Numerous studies have established a simple, degradation mechanism via homogeneous erosion. The degradation process occurs in two stages, the first involve the diffusion or water into the amorphous regions of the matrix and simple hydrolytic chain session of ester groups. The second stage of degradation involves largely the crystalline area of the polymer, which becomes predominant when the majority of the amorphous regions have been eroded.

In a study of Dexon sutures in vitro the first stage degradation predominates during the first 21 days and a further 28 days for the degradation of the crystalline regions, after 49 days, the reported weight loss is around 42% with complete loss of mechanical properties. Although the degradation product glycolic acid is resorbable at high concentration, they can cause an increase of localized acid concentration resulting in tissue damage.

The ultimate fate of glycolic acid in vivo is considered to be conversion to carbon dioxide and water, with removal from the body via the respiratory system.

Poly(lactic acid) is present in three isomeric forums D(-) L (+) and racimic (D, L) and the polymers are usually abbreviated to indicate the chirality. Poly (L) LA and Poly(D) LA are semi crystalline solids with similar rates of hydrolytic degradation as PGA.

PLA is more hydropholic than PGA. For most application the (L) isomer of lactic acid (LA) is chosen because it is preferentially metabolized in the body.

Effect of homopolymer and copolymer structures

It has been found that some of the biodegradable implant cause problem in the body since they take lot of time degradation because of the homopolymer structure. L-lactide, D-lactide, glycolide and tri-methylene carbonate (TMC) are single units known as monomers (Fig.1). These monomers can be formed in to chains called polymers Fig.2. For example, L– lactide monomers can join to form the Poly Llactide (PLLA).

Fig. 2 Polymers from monomers.

A polymer can consist or a single type of monomer creating a homopolymer (Fig.3) or a polymer can consist of two or more types of monomer creating copolymer (Fig.4)



Fig. 3 Representation of homo polymer.

Back | Back to Top | Previous | Next