Pharmaceutical Gelatin
- Pharmaceutical gelatin is a category of gelatin classified according to its uses and quality requirements.
- It is mainly used in the production of pharmaceutical products and covers both direct addition (such as in cod liver oil raw materials) and indirect use (such as in hard capsule packaging materials). It is commonly known as medical gelatin or pharmaceutical gelatin.
- It is commonly known as medical gelatin or pharmaceutical gelatin.
Application:
Soft Capsules, Hard Capsules, Plasma Substitute, Artificial Bone, Hemostatic Sponge, Wound Dressing, etc.
EDIBLE GELATIN
Pharmaceutical gelatin is an important fine chemical raw material with a wide range of applications. As a pharmaceutical gelatin, its quality directly affects public health and must be strictly controlled. Gelatin quality is mainly assessed from three aspects: its physical properties, chemical properties, and microbial limits. The current relevant standard for pharmaceutical gelatin in China is QB2354-2005, the Light Industry Standard for Pharmaceutical Gelatin.
Table: People’s Republic of China Light Industry Standard QB2354-2005 Pharmaceutical Gelatin
What Can We Do with Gelatin?
Pharmaceutical-grade gelatin typically requires a gel strength of 180 Bloom g or higher in various pharmaceutical production processes. Hard capsule production requires a gel strength of 200–250 Bloom g or higher, while the appropriate gel strength for soft capsule production and preparations such as ointments and suppositories needs to be adjusted according to the specific process. The main application of gelatin in the pharmaceutical industry is the production of soft capsules and hard capsules.
- Hard Capsule Production
Gel Strength Requirements: Pharmaceutical-grade gelatin used for hard capsule production generally has a gel strength of no less than 200 Bloom g. High-quality hard capsule gelatin should have a Bloom strength (i.e., gel strength) of 250–350 g. If the gel strength of the gelatin is less than 230 g, it is not suitable for making hard capsules.
Why?
The higher the gel strength, the higher the viscosity of the gelatin, resulting in capsules with stronger tensile strength and elasticity, uniform thickness, and less deformation.
Application of Gelatin
- Soft Capsule Production
Gel Strength Requirements: While the specific gel strength requirements for gelatin in soft capsules may vary depending on product characteristics and manufacturing processes, generally, gelatin with a certain gel strength needs to be selected to ensure the quality and stability of the soft capsules.
Influencing Factors: During the preparation of soft capsules, the gel strength, viscosity, and other properties of the gelatin will affect the capsule’s formability, elasticity, and stability.
- Other Pharmaceutical Applications
Ointments, Suppositories, and Other Formulations: In these formulations, the gel strength of pharmaceutical-grade gelatin also needs to be controlled within a certain range to ensure dosage form stability and ease of use. Appropriate gel strength ensures that the formulation maintains stable form and properties during storage and use.
Drug Sustained Release and Encapsulation: Utilizing the three-dimensional network structure of pharmaceutical-grade gelatin, the hydrolysis rate can be slowed down, achieving slow and uniform drug release. The drug release rate can be controlled by adjusting the gelatin concentration and adding cross-linking agents. In this process, the gel strength of the gelatin will also affect its encapsulation effect and drug release performance.
Inspection Standards for the Quality of Pharmaceutical Gelatin
The standards for testing the quality of pharmaceutical gelatin cover four main aspects: physical properties, chemical properties, microbial limits, and sensory requirements. Specific indicators and testing methods are as follows:
I. Physical Properties
* Moisture Content: Excessive moisture content may lead to product spoilage. The moisture content of pharmaceutical gelatin should not exceed 14% (some companies have stricter internal control standards, such as ≤12%).
Gel Strength: This measures the strength of the gel formed by gelatin under certain conditions. The gel strength of pharmaceutical gelatin should be ≥120 Bloom g (some standards may be higher, such as 275~280 g for gelatin used in hard capsules).
Brycero Viscosity: This reflects the viscosity of gelatin. The Blaine viscosity (6.67% solution) of pharmaceutical gelatin should be ≥2.6 mPa·s (specific values may vary depending on the standard).
Viscosity Decrease: This assesses the viscosity stability of gelatin under specific conditions. The viscosity decrease rate should be ≤10.0%.
Transmittance: …
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Pharmaceutical Gelatin For Your Various Product Needs
Pharmaceutical Gelatin-180 Gloom
180 gelatin is a medium-to-low strength gelatin. Its gel hardness meets basic pharmaceutical requirements and it is often used to prepare hard or soft capsule shells where mechanical strength requirements are lower. For example, in common traditional Chinese medicine capsule dosage forms, 180 gelatin can ensure that the capsules maintain their integrity during storage and transportation, while also being cost-effective.
Pharmaceutical Gelatin-200 Gloom
200-Strength Pharmaceutical Gelatin is a medium-strength gelatin suitable for the production of hard capsules with higher mechanical performance requirements. This product utilizes an alkali process to optimize molecular weight distribution, resulting in a gel network that combines elasticity and toughness. This effectively resists the mechanical stress of high-speed filling machines, reducing capsule breakage.
Pharmaceutical Gelatin-220 Gloom
220 Gel is a medium-to-high strength gelatin, suitable for pharmaceutical dosage forms with stringent requirements for mechanical strength and stability. This product is commonly used in the preparation of multi-layer tablet coatings or gel formulations that need to withstand significant pressure.
Pharmaceutical Gelatin-250 Gloom
250 Gel is a high-end pharmaceutical product. It is purified using an alkaline process combined with ion exchange technology and complies with EU EC No 853/2004 regulations. In pharmaceutical applications, 250 Gel is commonly used to prepare high-value-added dosage forms:
- Be used as a core raw material for hard capsules, ensuring that capsules remain intact during high-speed production lines (1200 capsules per minute).
- In the preparation of ophthalmic gels or suppositories, its high viscosity prolongs the drug’s residence time at the site of action.
- Be used as a substrate for 3D-printed biogels, it supports the molding of complex structures.
