Ministério dos Remédios – Tecnologia em Saúde

SUSYsystem is an innovative concept that integrates several products specifically designed with the aim of simplifying the preparation of oral liquid dosage forms allowing customization according to the specific needs of patients. SUSYsystem consists of a suspension vehicle, SUmir, a syrup vehicle, SYmir, and an flavoring system called SUSYflavor. The synergistic effect of the components of SUSYsystem allows the preparation of oral solutions and suspensions therapeutically active, with homogeneous dosages and of great galenic elegance.

Our two vehicles, SUmir and SYmir, have been designed to complement and form a colloidal aqueous base compatible with a wide range of active pharmaceutical ingredients.

The sophisticated composition of the SUmir Suspension Vehicle enables it to form a colloidal network capable of effectively suspending drug particles through the synergistic activity of its suspending agents and the formed matrix structure. Its thixotropic behaviour results in a “gel-to-liquid” system characterized by the transient decrease in viscosity when subjected to a force such as shaking the bottle. This change occurs by the momentary rearrangement of the cellulose fibres in the direction of movement. The consequent passage into the fluid liquid state facilitates the homogenization of the suspended particles, provides a more correct dosage and a smooth and pleasant swallowing. When resting, the three-dimensional network of the SUmir fibers regenerates and the viscosity returns to its initial state, contributing to slow the sedimentation of the particles.

Acting in a complementary way to the Suspension Vehicle, SYmir tmain function is to improve the organoleptic characteristics of the preparations, through its sweet taste (but without sugar), and its particular texture. SYmir helps to mask, quite effectively, the unpleasant taste of most drugs.

The third element that makes SUSYsystem is a set of flavours that allow the healthcare professional to customize the taste of the compounded medicine, according to the preferences of the patient. The SUSYflavor range has tastes directed to Paediatrics, Geriatrics and even Veterinary.
SUSYsystem is the most elegant and sophisticated way, available to Pharmacists, to develop formulations with all the guarantees of security and in a very fast and simple manner.

The composition of the SUmir includes purified water, xanthan gum, carrageenan, microcrystalline cellulose, sodium carboxymethylcellulose, sodium phosphate, citric acid, sodium benzoate, potassium sorbate and dimethicone. SYmir is composed of purified water, glycerin, sorbitol, sodium saccharin, xanthan gum, citric acid, sodium citrate, sodium benzoate and potassium sorbate.

Both SUmir and SYmir are ready to be used and no previous procedure is necessary.o previous procedure is necessary.

We should start by noting that the two vehicles have been studied and tested to be used always in the proportion of 50/50, ie for a preparation of 100ml we must use 50ml of SUmir and 50ml of SYmir, thus forming the SUSY vehicle. In general, the preparation of compounded medicines using SUSYsystem follows the following protocolnes using SUSYsystem follows the following protocol:

1. Calculate the required amount of the active pharmaceutical ingredient and the remaining components to obtain the desired concentration;
2. Decondition the drug (eg tablets or capsules) or use the pure drug raw material. Grind to a fine, homogeneous powder using a porcelain mortar.
3. In a measuring cylinder, according to the desired final volume, mix the SUmir and SYmir in the ratio 50/50 to form the SUSY vehicle.
4. Add a small amount of SUSY vehicle to the mortar and grind in order to moisten the powder and form a homogeneous paste;
5. Add the remaining SUSY vehicle by geometric dilution until it reaches about 2/3 of the final volume;
6. Transfer the contents of the mortar to a measuring cylinder by repeatedly rinsing with the SUSY vehicle;
7. Add the chosen flavour of the SUSYflavor range;
8. Complete the volume with the remaining SUSY vehicle and homogenise;
9. Pack in appropriate container and label.

SUSYsystem has been designed and developed for situations in which there is no medicinal product suitable for the needs of a particular patient. Be it by the lack of: a product containing the desired active pharmaceutical ingredient, a certain concentration, suited pharmaceutical form, by the presence of contraindicated excipients, or even by organoleptic characteristics that could hinder the acceptance by the patient. Although in theory any patient can benefit from personalized medication, the situations in which SUSYsystem should be used are usually related to Neonates and Paediatric patients, Geriatric patients with dysphagia or nasogastric probes and administration of drugs in Veterinary Medicine.

Since SUSYsystem vehicles do not contain sugars in their composition, they can be used in the preparation of formulations for diabetics and obese people or people with caloric restrictions.

SUSYsystem vehicles do not contain alcohol, sugar, colourings, aromas, gluten, parabens or propylene glycol and its use is recommended Neonatology.

The existence of two supplementary vehicles, SUmir and sweetening vehicle (SYmir), gives more versatility to the system as there are situations where the combined use of SUmir and SYmir may not be necessary or even inadvisable. Some examples:

• Formulas for patients intubated with nasogastric tubes do not need to use the sweetener vehicle, SYmir, since in this circumstance the organoleptic characteristics are irrelevant to the patient;
• Formulas for newborns may not require the use of the sweetener, SYmir, since there is no need to improve organoleptic characteristics in these patients.
• Preparations using highly hydrosoluble active pharmaceutical ingredients which result in an oral solution do not require suspending agents, and the use of SUmir is not required;

The presence of the sweet taste conferred by SYmir on Veterinary preparations may compromise adherence to therapy by some animals, particularly exotic species.

The stability table drawn up by Ministério dos Remédios includes more than 100 active substances and is constantly being updated, as we have data from new trials. However, it may happen that the API you intend to use does not appear on the chart and in this case, you should contact our company which will provide you with the necessary information and recommendations regarding the preparation and stability of the drug concerned.

Ministério dos Remédios has developed a recommended stability chart for the API compounded with SUSYsystem, which is constantly updated as we have data from new trials. This table contains the recommendations for the shelf-life to be given and the storage conditions of the prepared medicinal product. It is important to take into account that the stability of a tampered medicinal product can be conditioned by numerous factors, such as the origin of the API (deconditioning of commercial specialties), its concentration, the preparation technique and the equipment used, possible contamination and even the experience of the compounding professional. Thus, assigning an expiration date to the end product is always the responsibility of the Pharmacist. The SUSYsystem stability table developed by us is for guidance only, although it is based on stability tests of the various scientific bibliographies available.

In fact, some drugs such as proton pump inhibitors, folic acid or furosemide, for example, require an alkaline pH to remain stable. In such cases, the use of SUSYsystem is still recommended although it is necessary to change the pH of the formulation to the desired values by adding a base, for example a solution of sodium bicarbonate or a solution of sodium hydroxide.

SUSYsystem may be used to deliver any hydrophilic or hydrophobic API provided it is stable in aqueous medium and at acidic pH. Ministério dos Remédios has developed a recommended stability chart for the SUSYsytem API, which is constantly updated, as we have data from new trials. The shelf-life after preparation, as well as the storage conditions recommended in the table, are in accordance with the scientific literature for stability tests based on formulations for U.S. Pharmacopeia Convention..

SUSYsystem should not be used in patients with hypersensitivity to any of the components of SUmir, SYmir or SUSYflavor. Likewise, if the product to be prepared contains a substance that is unstable in an aqueous medium, SUSYsystem vehicles should not be used.

SUSYsystem vehicles do not contain alcohol, sugar, colouring agents, flavours, gluten, parabens or propylene glycol, which minimizes the risk of allergies or intolerance.

The thixotropic behavior results in a “gel-to-liquid” system characterized by the transient decrease in viscosity whenever a force is applied, for example, agitation of the bottle. This change occurs by the momentary rearrangement of the cellulose fibers in the direction of movement. The consequent passage into the fluid liquid state facilitates the homogenization of the suspended particles, provides a more correct dosage and a smooth and pleasant swallowing. When resting, the three-dimensional network of the SUmir fibers regenerates and the viscosity returns to its initial state, contributing to slow the sedimentation of the particles.

SUSY, the final result of the SUmir mix with SYmir, has an opaque white colour that masks any insoluble particles, giving in these cases the appearance of a more homogenous suspension. This is particularly important when we resort to deconditioning pharmaceutical specialties. The texture is soft and not viscous, pleasant to swallow.

At present the SUSYflavor range includes flavours for children, adults and also for Veterinary For human use we can find strawberry, cherry, banana, vanilla, chocolate, chewing gum and marshmallow. Animal flavours include fish, liver and meat.

The personalization of the organoleptic characteristics of oral liquid medicinal products, using different flavours, is proposed in almost all the bibliography of pharmaceutical manipulation, without taking into account the qualitative and quantitative composition. No incompatibility of flavourings API used in pharmaceutical manipulation is considered in the literature, and these inert products are thus considered as long as they do not alter the physico-chemical characteristics of the starting product or cause other visible instabilities, such as the formation of precipitates. There is no legal description in the pharmacopoeias of any pharmaceutical flavour. SUSYflavor flavourings are suitable for food use and comply with EU food law. They do not alter the initial characteristics of the vehicles, considering their inert action in the recommended concentrations from the point of view of the physico-chemical stability.

Foaming during the preparation of the compounded medicine, or shaking the suspension at the time of administration, may compromise the concentration or volume which we intend to administer. This problem is frequent, especially in cellulosic vehicles that are prepared in situ. The SUmir formulation was carefully and specifically designed to bypass this problem and therefore includes an antifoaming agent, dimethicone.