Healthcare
TYLOPUR®, Hydroxy propyl methyl cellulose is produced in Germany by SE Tylose GmbH &Co. KG. Several grades of Hypromellose are available and differ in their viscosity and substitution.
They are compliant to the substitutions listed in the three pharmacopeias USP (USA), JP (Japan) and EP (Europe), respectively. In 2021, the GMP production site was certified Excipact successfully.
The TYLOPUR® grades are nonionic cellulose derivatives by nature. This property confers a good stability with a wide range of active ingredients. Furthermore, hydroxy propyl methyl cellulose is a water soluble polymer. Thus the TYLOPUR® grades available generate clear solutions once dissolved into water. Those solutions will have different viscosities depending on the amount and grade of TYLOPUR® used.
| Grades | Description | Regulatory | Origin | Knowledge Base | ||||||||||||||||||||||
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| 603 | Hypromellose 2910, 3 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 645 | Hypromellose 2910, 4.5 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 605 | Hypromellose 2910, 5 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 606 | Hypromellose 2910, 6 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 615 | Hypromellose 2910, 15 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 60SH-50 | Hypromellose 2910, 50 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 60SH-4000 | Hypromellose 2910, 4000 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 60SH-13000 | Hypromellose 2910, 13000 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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| 65SH-5 | Hypromellose 2906, 5 mPas | USP, EP, JP, EXCiPACT | Germany | Select | ||||||||||||||||||||||
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Adding the TYLOPUR® powder directly into cold water can be challenging as lumps can easily be formed due to the incomplete wetting of the powder.
One method to avoid the lump formation is to take the advantage of the insolubility of hydroxyl propyl methyl cellulose in hot water (>70°C). After cooling down, the hydroxyl propyl methyl cellulose hydrates and dissolve fully. The hydration temperature depends on the substitution grade of hypromellose. For the TYLOPUR® types, this temperature should be below below 40°C and ideally less than 10°C. Thus a cooling bath is recommended for the preparation of the hypromellose solutions generally.
TYLOPUR® can be dissolved in organic solvents as well. Typical examples are a combination of ethanol and water or isopropanol and water.
Hypromellose solutions are stable over a wide pH range, going from pH 3 to pH 11.
TYLOPUR® consists of hydrophilic and hydrophobic groups and thus can be considered as well as a non-ionic surfactant. This attribute provides function such as protective colloid to stabilize emulsions, suspensions or foams. The surface activity will depend on the substitution type. The lowest surface activity is obtained with the TYLOPUR® grade 60SH, which makes it a good candidate for artificial tears formulations, for example. Low viscosity hydroxyl propyl methyl cellulose grades are suitable for coating and granulation application.
TYLOPUR® 603 till 615 are ideal grades for the coating of oral solid dosage forms.
The tablet coating using hypromellose became popular because it is an easy method to protect fragile tablets and provide a smooth surface of the coated tablets. Another advantage for the extensive use of TYLOPUR® low viscous in coating applications is its solubility over the entire biological pH.
One of the main advantages using TYLOPUR® grades in tablet or pellet coating is the ability of hypromellose to form transparent and flexible films from aqueous solutions.
The most popular grades for tablet coating are the TYLOPUR® 605 and 606. In case of fragile tablets, TYLOPUR® 615 is recommended, whereas TYLOPUR® 603 can be used for pellet coating. Low viscosity hydroxyl propyl methyl cellulose grades are also one of the major products used for capsules coating or capsules banding. The aim of this application is to seal the gap existing between the two parts of the capsules in order to avoid any liquid penetration.
In order to easy differentiated from each other oral solid dosage forms having the same shape, pigments can be added to the hypromellose film solutions. In case that case, the film flexibility is decreased. Thus, we recommended to add plasticizers in the coating formulation. Furthermore, talc can be added to the coating formulation to optimize tablets slipping during the packaging or reduce the tackiness of tablets and pellets during the coating process.
Hydroxy propyl methyl cellulose is an effective and widely used binder in wet granulation processes. It has superior stability due to its non-ionic character, hence it does not interact with drugs. TYLOPUR® 603, 605 or 606 are used either in dry form or in the binding solution. Both are used in typical wet granulation processes like fluid bed granulation or high shear granulation. The obtained granules show an improved flow property compared to the initial powder. They can then be compressed into tablets or filled into capsules or directly into sachets.
Hydroxy propyl methyl cellulose films show as well interesting properties for the manufacturing of hard capsules. Thus, low viscosity TYLOPUR® is used to replace gelatine in this application.
The main advantages over gelatine are the better moisture stability as hypromellose is less moisture sensitive and its plant derived origin. The optimal solution for patients who follow a vegetarian or vegan diet.
| Application |
|---|
| Tablets & Pellets |
| Tablet coating |
| Pellet coating |
| Taste masking by coating with enteric polymer and pore former |
| Sustained release (matrix tablets) |
| Binder solution for wet granulation (WG) |
| Capsules |
| Capsule Shell |
| Amorphous Solid Dispersion (ASD) |
| Solvent free methods (HME) |
| Solvent methods |
| Liquid and Others |
| Thickening |
| Eye drops |
| Suspending |
| Dry syrup |
| Plaster/ Dermal Patch |
| Oral films |
| Continuous Manufacturing (CM) for Oral Solid Dosage Form (OSD) |
| Wet granulation (WG) immediate release (IR) |
| Wet granulation (WG) sustained release (SR) |
| Roller compaction (RC) sustained release (SR) |
| Direct compression (DC) sustained release (SR) |
| Tablet coating |
| Pellet coating |
| Amorphous solid dispersion (ASD) |
| TYLOPUR® | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 603 | 645 | 605 | 606 | 615 | 60SH-50 | 60SH-4000 | 60SH-13000 | 65SH-5 | |
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• Suitable / •• Very Suitable
The Shin-Etsu team is supporting all technical, quality and regulatory related questions. Our team of sales and technical sales manager supports you to develop your products, or during issues at your manufacturing process. Shin-Etsu has long year experience in cellulose ether business and is aiming to give you the best possible guidance and high quality products manufactured in Japan and Germany.
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Shin-Etsu is an excipient manufacturer with an emphasis on a stable supply of high-quality products.
The production plant operates under GMP conditions and fulfils the requirements of the pharmaceutical, food and nutraceutical industries.
TYLOPUR® DG-4T is a new grade for hand sanitizer gel, which can be easily used in formulations with more than 60% alcohol, giving a transparent gel.
TYLOPUR® DG-4T grade is similar to TYLOPUR® 60SH-4000, shown in the video.
