Integrated Solution Of Solid Preparation
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I. Introduction:
The common solid dosage forms are powders, granules, tablets, capsules, drop pills, pellicles, etc., which account for about 70% of pharmaceutical preparation. Compared with liquid pharmaceutical preparations, the common features of solid preparation are good physical and chemical stability, low production cost, convenience for taking and carrying, the same pretreatment operations during preparation ensures uniform mixing and accurate dosage of medicine, close association among different dosage forms and dissolution of medicine in body before penetration of biological membrane and absorption to blood circulation system.
During preparation of solid dosage form, drugs are crushed and screened before processing into different forms. Powders are obtained if direct packaging is performed after uniform mixing with other ingredients; granules are obtained if packaging is performed after granulating and drying of uniformly mixed materials; tablets are obtained if prepared granules are compressed and formed; and capsules are obtained if mixed powders or granules are encapsulated. For solid preparation, mixedness, liquidity and filling ability of materials are very important, for example, crushing, sieving and mixing are main unit operations to guarantee content uniformity of medicines and almost all solid preparation shall go through above operations. Good liquidity and filling ability of solid materials can assure accurate dose of products and use of granulator or fluidizer is one of measures to improve liquidity and filling ability.
II. Detailed introduction:
1. Weighing: The best process precision is critical to pharmaceutical industry. The weighing and distribution system plays a significant role in quality of the whole production process of oral solid drugs. Accurate weighing is conducive to raw material management, compliance with regulatory requirements and product quality improvement. The advantages are as follows:
★ Best weighing precision
★ Flexible solutions
★ Intelligent transfer equipment meeting human body engineering
★ High precision under wide weighing range, especially applicable to full-automatic system
★ Optional highly closed equipment
2. Wet and dry granulating: All granulating systems can realize simple and efficient processing. We process a whole granulator series from laboratory granulator to granulators in batch production with production capacity of one pot up to 750kg and can provide various optional functions and product extension schemes for wet and dry granulating, thus realizing easy customization or special application configuration. The advantages are as follows:
★ Full product series: wet and dry granulating
★ Simple operation and fast cleaning
★ High economic benefit, resource protection and high efficiency
★ Applicable to laboratory and batch production
★ Various option and product extension schemes
3. Sieving: Grinding and sieving machine are considered as the most advanced precision granularity reduction facility according to industry standards. Hammer grinder, sieve system and rotary screen are suitable for continuous and batch production as well as research and product development. The advantages are as follows:
★ Rich application choices
★ Less dust generation
★ Less heat generation
★ Compact GMP design
★ Easy cleaning of rotor and enclosure
★ Repeatable and uniform result
4. Mixing: Mixing of powders during pharmaceutical production involves high safety and sanitary requirements. For production of solid preparations, homogeneity of mixture is critical in mixing and uniform distribution of all ingredients of mixture is the objective of this process.
5. Coating: Film coating is a key step with hard requirements in tablet production. The coating machine can guarantee outstanding product processing effect and cost benefits. The film coating process contains the following basic operations:
★ Spraying
★ Mixing
★ Drying
6. Inspection: it is a cost-effective mechanical inspection on thickness of tablets with sugar coating or film coating and one of the main standards for solid preparations.
7. Transfer: Perfect transfer makes a vital contribution to optimization of production process: whenever supply of raw materials or transportation, safe sealing or storage of products is needed, all kinds of containers and lifting system are used. Handling solution of solid preparations is applicable to careful transfer of drugs. We provide customized solutions for storage, transportation and system interface in a multi-functional form and support optional coordination or connection among steps.