Various quality factors to bear in mind for Semi Solid Manuafacturing
Manufacturing semi solid pharmaceutical drugs calls for specialized production techniques for high-end outcomes. Semi-solid pharmaceutical drugs include ointments, creams, gels, pastes, handwash etc.
There are a number of factors needed to be taken into account during the production of semi-solid pharmaceuticals. You must know that you got to comply with cGMP norms while producing semi-solid dosage forms or other pharmaceutical products. They got to be cosmetically elegant, smooth in touch and minimize any dehydration or grittiness. Users do not feel any sort of irritation on skin while using these products. Pleasant smell is also one of the characteristics of these nicely manufactured pharma products. One can easily apply them on the affected area using plastic or aluminum tubes. You must also know that there are a whole host of domestic and international standards which have been adopted to maintain efficiencies in the manufacturing process. These norms or standards are: statistical Design of Experiments (DoE), Failure Mode and Effects Analysis (FMEA), and Quality by Design (QbD). These norms are in place to eliminate any kind of risks.
Five Key Characteristics to Watch Out For
The quality of semi-solids production manufacturing basically boils down to 5 key properties such as particle distribution, homogeneity, grittiness, spreadability, and surfactants. Each of these elements is equally critical to the production process which means that failure of any of these leads to compromised quality and hence all of these must be very closely monitored. This helps ensure that consumers and patients get the right medication and product complying with all pharmaceutical standards.
As you know homogeneousness refers to the state of ‘being all of one kind’. There must be a proportionate distribution of all ingredients. API distribution and other ingredients got to be uniform in all container closure systems. If you are manufacturing creams then there will be two separate phases involved in the process such as oil phase and water phase. The degree to which these two elements are treated determines the quality of the product.
Particle size distribution is a vital consideration apart from distribution and shape. They can immensely impact the usability, performance and stability of the end product. Uniform particle sizing techniques are indispensable to the manufacturing of these products. There is an ever-increasing need to meet these standards.
The therapeutic value of a semi-solid pharmaceutical drug product is determined by the degree of spreadability. The action of a product when applied on skin or other surfaces can be understood as spreadability. The product distribution gets affected with the degree of spreadability and hence it is a key element.
Grittiness is avoided in the production of semi-solid pharmaceutical drug manufacturing. It is directly related to particle shape and size and hence top-drawer semi-solid products have little or grittiness at all.
Last but not the least surfactants are a vital factor in the production of semi-solid dosage forms. They are immensely crucial and are considered instrumental in the facilitation of combining aqueous and oil phases pretty well during the process.
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