How Pharmaceutical Ointment Manufactured?

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How Are Pharmaceutical Ointment Manufactured?

Pharmaceutical ointments, creams and gels are an integral component of many treatments for various medical conditions. Their production requires careful blending techniques as well as strict compliance to hygienic guidelines for production.

Digital microscopy was utilized in this research project to reveal that petrolatum ointment samples varied significantly depending upon manufacturing conditions, with its chemical composition changing significantly between samples. Furthermore, its pharmaceutical properties were also affected by these differences in composition.

The Manufacturing Vessel

Manufacturing vessels are used for making ointment. Melted oil and water are combined in this container while heated and stirred, to ensure even distribution and mixing. Drug components (if any remain) may also be added here before mixing, using either an emulsifier or homogenizer to achieve even mixing.

Once the ointment is ready, it is transferred from one vessel to the other via pipes through a bump pump equipped with electropolished walls that prevent it from reacting with any components in its tank. Furthermore, this pump boasts a large working platform and control panel to help operate this machine efficiently.

Pharmaceutical ointments have long been used for various medical and cosmetic uses, such as treating haemorrhoids. With three pharmacological effects combined in one application, making it an efficient medicine that is simple and straightforward to manufacture in hospital pharmacies using guidelines established by Pharmaceutical Inspection Convention.

The Homogenizer

Homogenization is a physical process for mixing immiscible liquids to form an emulsion. The process entails forcing fluid through a small gap at high pressure, creating turbulence and pressure differences which disrupt and disperse particles into dispersion. Homogenizers are widely used across food, pharmaceutical, and chemical industries and serve multiple functions like reducing particle sizes, breaching cell walls or membranes and the destruction of pathogens.

Homogenization allows for uniform distribution of both drug and base in an ointment product, and helps avoid formation of agglomerates or dead spots which could otherwise result in product waste. When applied to haemorrhoid treatment ointment products, homogenization helps achieve three pharmacological effects simultaneously:

A shear-type homogenizer equipped with paddle mixer and jacket structure container equipped with an attached temperature sensor was utilized for manufacturing petrolatum ointment samples. Results revealed that when mixed at 40 degC for final mixing temperature, an ointment with lower rheometer hardness and bleeding ratio was produced using this manufacturing condition. Furthermore, shear-type homogenizer enabled production of an ointment similar in texture, pharmacological properties, stability, drug release rates compared with one produced using conventional fusion method production conditions.

The Storage Tank

Storage tanks are used to temporarily store ointment until production begins, providing safe and durable options for processing plants. Constructed from high-grade stainless steel for safety and durability, insulated for heat loss protection to maintain an ideal temperature throughout production, working platform for operators during their ointment creation and even an integrated working platform are some features unique to storage tanks that make this an essential piece of equipment for keeping production at an optimum level.

Ointment manufacturing is a critical step in pharmaceutical production. Manufacturing conditions can dramatically alter their composition, altering internal structures of ointments and altering their pharmaceutical properties; among these conditions, mixing temperature after melting white petrolatum is one of the key influencing factors.

To assess this factor, ointment samples were produced under different conditions and characterized using GC-MS and microscope observation. Results demonstrated that their properties were strongly affected by their internal structure consisting of needle crystals surrounded by spherical aggregates connected by semisolid components; samples mixed closest to their melting points had lower bleeding ratio values, while those mixed at higher temperatures showed greater hardness values.

Additionally, the distribution of linear saturated hydrocarbons within each sample was evaluated using a gas chromatograph mass spectrometer. Each ointment sample contained equal amounts of standard linear saturated hydrocarbon reagents dissolved in hexane solvent.

The Filling Machine

This component of the plant is key in moving ointment from storage vessel to tubes for dispensing. A highly-efficient metering pump controls flow rate according to Bernoulli’s principle, while electropolished walls help avoid reactions during transfer process.

Pumps come equipped with hoppers that collect calculated amounts of ointment that need to be filled into each tube, before being sent onward to be processed through various steps like pressing, crimping and coding to ensure quality products. Air bubbles must also be eliminated so as to provide quality output.

Cooling petrolatum causes changes to its physical properties which affect its pharmaceutical characteristics, leading to ointments with different pharmaceutical characteristics than expected. Both cooling temperature and mixing conditions play an integral part in shaping these properties of an ointment’s final formulation.

A rheological study was undertaken to ascertain the impact of various mixing processes and temperatures on the physical properties of ointments, particularly their shear resistance and elastic modulus properties. Results of this analysis were plotted on a G’ versus shear stress logarithmic graph with each point where two tangents crossed being estimated as yield stress (synopsis Fig 6b).

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