Drug-Eluting Sutures by Hot-Melt Extrusion: Current Trends and Future Potentials
Abstract
:1. Introduction
2. Drug-Eluting Surgical Sutures
2.1. Unique Advantages of Drug-Eluting Sutures
- Localised discharge of antimicrobial agents, anti-inflammatory drugs, analgesics, local anaesthetics, extracellular matrix proteins, and cytokines to the wound site.
- Eliminate the toxicity and/or side effects associated with peroral and/or parenteral drug administration.
- Reduce or eliminate the development of surgical site infections.
- A combination of multiple drugs, e.g., antimicrobial agents and anti-inflammatory drugs in the same suture, can exhibit synergistic effects and/or additive effects on the affected site.
- Better therapeutic concentration with prolonged duration can be achieved with amplified loading of drug and sustained drug delivery.
- Better and faster wound healing and tissue regeneration.
- Enhanced mechanical properties, especially when the loaded drug(s) act as a filler to reinforce the tensile strength of the suture threads.
- Applicable for use in invasive surgeries, regenerative medicine, and tissue engineering.
2.2. Production Methods of Drug-Eluting Sutures
2.3. Production of Drug-Eluting Sutures by Hot-Melt Extrusion
2.4. Advantages of Hot-Melt Extrusion in Drug-Eluting Suture Fabrication
- HME can disperse a single or combination of different APIs in the polymer matrix at the molecular level with the likelihood to enhance the dissolution of poorly soluble drugs when they form amorphous solid dispersion of the drug–polymer blend.
- APIs can be homogeneously distributed into the suture cross-section. Hence, achieving prolonged drug release.
- It is a one-step continuous process, hence, can be easily scaled up, making it easy to translate from laboratory to commercial production.
- There is no need to dissolve the suture-forming polymer prior to drug-loading.
- The process does not require any solvent recovery, which can be costly.
- HME process is devoid of risk of solvent explosion or additional drying procedure that may be detrimental to the drug and/or drug–polymer mix.
- There is no residual solvent in the suture, therefore, less undesired and/or side effects to the application/wound site.
- A quantitative yield of 100% is achievable.
- HME is a safer, environmentally friendly, and ‘greener’ technology for thermostable drugs than organic-solvent-based techniques for drug-eluting suture preparation. Hence, it is a cheaper technique.
- HME can be coupled with melt electrospinning, and thus, continuous manufacturing is feasible [49].
- Melt-spun sutured filaments are usually void-free, with diameters and tensile strengths within the USP limits [70].
2.5. Limitations of HME for the Production of Drug-Eluting Sutures on Drug Half-Life
2.6. Material Requirements for HME
3. Critical Quality Attributes of Drug-Eluting Sutures and Their Assessment
- Failure load is the load in Newton (N) at which the integrity of the suture thread is lost.
- Elongation at break (E%): Because of stress applied to suture material during the TS test, the dimension of the suture is stretched, resulting in strain generation. Percent elongation at break is determined by dividing the extension at the moment of suture break (L) by the initial gauge length of the specimen (L0) and multiplying by 100 according to Equation (1):
- Young’s modulus is calculated as the slope of the linear portion of the stress–strain curve. It is the measure of suture stiffness. Hard and brittle sutures are likely to have high Young’s modulus values and high TS.
4. Future Perspectives
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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HME Apparatus and Condition | Model Drug(s) | Suture Polymer/Excipients | Suture Structure | Suture Diameter (µm) | Special Features and Advantage | References |
---|---|---|---|---|---|---|
Extrusion was performed at 63 ± 1 °C for 5–20 min while mixing and extruded using a hot-melt extruder (CSI LE-075, PA, USA). | Diclofenac potassium | Polyethylene glycol-Poly(ε-caprolactone-chitosan-keratin blend | Monofilament | 500–700 |
| [38] |
HAAKE twin screw extruder using a screw speed of 20 rpm and applying a temperature profile going from 60 °C, at the feed zone, to 100 °C at the die zone | Nanohybrid ofhydrotalcite andDiclofenac (HT-Dic) | Poly(ε-caprolactone) (PCL) | Monofilament | 300 |
| [57] |
Counter-rotating twin-screw compounder (Brabender, D045 mm, L/D07) with a thermal profile of 40–50–70–100 °C and a speed of 64 rpm. | Chlorhexidinediacetate (CHX) | Poly(caprolactone) (PCL) | Monofilament | 300 ± 10 |
| [56] |
Dynisco extruder hopper and sutures were extruded from a melted mixture of PLGA pellets and lyophilised CpG ODN at about 70 °C | Cytosine–phosphorothioate–guanineoligonucleotides (CpG ODN) | Polylactic acid-co-glycolic acid (PLGA) | Monofilament | 600 |
| [68] |
The polymer was melt-spun at 180 °C under nitrogen, allowed to heat up for 10 min, and fibres drawn at 192 °C | Nitric oxide (NO) | Acrylonitrile-co-1-vinylimida-zole (AN/VIM) copolymer.polycaprolactone (PCL) used as a secondary coating | Monofilament | 0.366 |
| [69] |
Drug polymer melt was extruded in a Collin Zk25 twin-screw extruder using a temperature profile along the extruder with six heater zones set at 70, 80, 80, 75, 70, and 60 °C from the feed to the die end and a screw speed of 60 rpm. | Ibuprofen | Poly(ε-caprolactone) (PCL) | Monofilament | Not provided |
| [66] |
HAAKE MiniLab micro compounder (Thermo-Haake, Karlsruhe, Germany) at 155 °C and screw speed of 20 rpm | Carvedilol | Eudragit® E | Monofilament | 20 |
| [55] |
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Khalid, G.M.; Billa, N. Drug-Eluting Sutures by Hot-Melt Extrusion: Current Trends and Future Potentials. Materials 2023, 16, 7245. https://doi.org/10.3390/ma16227245
Khalid GM, Billa N. Drug-Eluting Sutures by Hot-Melt Extrusion: Current Trends and Future Potentials. Materials. 2023; 16(22):7245. https://doi.org/10.3390/ma16227245
Chicago/Turabian StyleKhalid, Garba M., and Nashiru Billa. 2023. "Drug-Eluting Sutures by Hot-Melt Extrusion: Current Trends and Future Potentials" Materials 16, no. 22: 7245. https://doi.org/10.3390/ma16227245