DRIED ALUMINIUM HYDROXIDE GEL 250MG + MAGNESIUM HYDROXIDE 250MG + SIMETHICONE 50MG SUSPENSION

Each 10 mL of this suspension contains Dried Aluminium Hydroxide Gel 250 mg, Magnesium Hydroxide 250 mg and Simethicone 50 mg in an appropriately formulated liquid pharmaceutical vehicle.
This multi-ingredient suspension formulation requires stable dispersion of the solid and dispersed ingredients to ensure the composition remains relatively consistent throughout the suspension.
Formulation development of multi-component suspension formulations focuses on the nature of the solids present (such as mineral or gel particles), and the sedimentation profile, the viscosity of the suspension, its ability to redisperse after shaking, and the pH and dose-volume relationship of the finished product.
Development of a pharmaceutical product portfolio for a PCD Pharma Franchise can include this type of suspension into a carefully devised range of liquid products with the necessary quality characteristics and appropriate packaging.

Composition of a Suitable Liquid Vehicle

The liquid vehicle must maintain a good dispersion of the Dried Aluminium Hydroxide Gel, Magnesium Hydroxide and Simethicone, which can involve different physical properties of each component.
The physical state of the Dried Aluminium Hydroxide Gel and Magnesium Hydroxide is that of a dispersed solid material, while that of the Simethicone is that of a dispersed phase, so the liquid vehicle should be selected to suit these ingredients.
Involved excipients, depending on the desired physical characteristics of the suspension formulation, may include suspending agents, wetting agents, viscosity modifiers, sweeteners, flavours, preservatives and other pharmaceutical formulation aids and excipients.
Preformulation investigations can measure particle size, sedimentation, pH, viscosity, density and compatibility of the ingredients with each other and the proposed excipient system.
The goal is to establish a suitable formulation that remains physically stable during storage, so that the suspended components stay physically dispersed during use and can be stirred back into suspension if they do settle.

Dispersion of Ingredients and Wetting of Particles

Properly wetting the Dried Aluminium Hydroxide Gel and Magnesium Hydroxide should take place during formulation, if necessary, before they are incorporated into the bulk preparation.
Wetting agents and dispersing systems may require careful control to be added at the most appropriate stages of the process, in order to prepare them for eventual addition into the final formulation.
Simethicone may need special dispersion technology to be used during formulation, depending on the complexity of the formulation design, as its physical behaviour during mixing is different from that of the mineral components.
Particle-size distribution is also an important determinant of sedimentation and redispersion behaviour, so the particle size should be monitored if applicable.
Ultimately the aim is to produce a suspension in which the formulation components stay suspended during storage and are dispersed when shaken before use, according to the product label instructions.

Bulk Formulation and Manufacturing

Bulk preparation of the suspension involves confirming the identity and specification of the raw ingredients and formulation components according to validated specifications.
The vehicle is made up in a suitable manufacturing vessel prior to the addition of the formulation ingredients, according to the composition and sequence established during development.
Suspending or viscosity-modifying agents should be properly hydrat ed or dispersed before addition of the active ingredients.
The mineral components can be added by appropriate agitation to allow proper dispersion, with control of mixing speed and time during addition.
Simethicone can be added at a well-defined point in the process for good distribution in the bulk, without overshoot of the proportion in the preparation.
In-process assessments can monitor the appearance, pH, viscosity, density, homogeneity and other pertinent properties of the bulk suspension.
The bulk suspension is then maintained in a controlled environment before the final filling stage, to prevent settling or segregation of the ingredients.

Quality Control and Physical Evaluation

Assessment of the finished suspension includes chemical analysis of the individual ingredients according to validated test procedures and product specifications.
Finished-product assessment includes appearance, colour, odour, pH, viscosity, density, volume of fill, sedimentation characteristics and ability to redisperse after storage, according to the agreed product specifications.
Assay analysis can be performed with validated test procedures suitable for each ingredient, and determined against appropriate standards.
Microbiological status is also tested in accordance with the finishing product specification.
Sedimentation volume and redispersibility can be checked over the product shelf life, together with any change in the physical properties of the product such as viscosity.

Storage, Container Compatibility and Shelf-Life

An adequate shelf-life can be determined based on the stability of the physical and chemical characteristics of the preparation, at periodic testing points.
The container material should be selected so that the necessary vigorously shaking of the bottle or pack can be conducted during use of the product, without degradation of the bottle or container material or the product itself.
The container-closure system should not impart any unacceptable physical or microbiological contamination or effects on the suspension.
The container size and shape should allow easy identification of the product, good protection of the contents and would be suitable for the product application.
Based on the physical and chemical character of the suspension, appropriate stability studies can be carried out, to support the shelf-life and storage conditions.

Formulation Range for a PCD Franchise Organization

This Aluminum Hydroxide, Magnesium Hydroxide and Simethicone suspension formulation range can be incorporated into a broad and carefully developed liquid formulation portfolio for a pharmaceutical organization.
Working as a PCD Franchise partner, the portfolio can be supplied with each product shown with its accurate composition, pack details and manufacturer information, and with the appropriate product specification and stability data.
Artwork for the packaging of the product can be developed to reflect its accurate composition, and should meet industry and regulatory standards.
Development of the original formulation involves several elements of specialist research, from raw material qualification and liquid vehicle preparation, through wetting of ingredients and compositional formulation, to bulk manufacture and packing, to final quality control and stability assessment.
All of these areas are important considerations for manufacture, and they come together to produce a pharmaceutical suspension formulation with controlled dispersion, granule behaviour and liquid-phase characteristics.