Compounded Capsules in Our Pharmacy Laboratory: Personalised Preparation with Quality, Precision and Professional Care

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Personalised capsule compounding in our pharmacy laboratory

At our pharmacy, we operate a dedicated galenic laboratory where we can prepare personalised compounded capsules when there is a valid medical prescription or clear therapeutic instruction for an individual patient.

Compounded capsules are not mass-produced products. They are prepared for a specific person, according to the therapeutic need assessed by the prescriber and under the professional responsibility of the pharmacist who prepares and dispenses the formulation.

This makes pharmacy capsule compounding an important service for patients who may need a personalised dosage form, a specific capsule strength, or a formulation that is not readily available as a standard commercial product.

What are compounded capsules?

Compounded capsules are hard-shell capsules prepared in a pharmacy laboratory by carefully measuring, blending and filling powders into empty capsule shells.

They may contain an active ingredient prescribed by a doctor, together with suitable excipients that help the powder mixture flow, fill the capsule correctly and remain consistent throughout the batch.

In simple terms, compounded capsules allow the pharmacist to transform a prescribed formulation into an easy-to-use oral dosage form, always within the framework of the prescription and the applicable pharmaceutical standards.

Who instructs the pharmacist to prepare compounded capsules?

The instruction to prepare compounded capsules comes from the prescriber, usually through a medical prescription or a clear therapeutic instruction for a specific patient.

The pharmacist does not create a treatment independently. The prescriber identifies the therapeutic need, while the pharmacist evaluates whether the formulation can be prepared appropriately and safely in the pharmacy laboratory.

The pharmacist’s role is to:

• review the prescription,

• assess the pharmaceutical suitability of the formulation,

• choose appropriate excipients,

• calculate the quantities required,

• prepare the capsules using suitable equipment,

• check the final product,

• package and label the preparation correctly,

• provide the patient with the correct instructions for use.

This collaboration between prescriber and pharmacist allows compounded capsules to be prepared responsibly and individually, according to the needs of the patient.

Why can capsules be prepared in a pharmacy?

Pharmacy compounding exists to cover individual patient needs that are not always met by ready-made commercial medicines.

In the European framework, a magistral preparation is understood as a medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient. This is the legal and professional foundation that allows pharmacies to prepare personalised formulations, such as compounded capsules, when they are needed and properly prescribed.

This service does not replace industrially manufactured medicines. Instead, it provides an individualised solution when a standard product is not suitable, not available, or not aligned with the specific prescribed requirement.

When might compounded capsules be useful?

Compounded capsules may be considered when the prescriber needs a specific oral dosage form or an individualised formulation.

Examples may include situations where:

• a specific capsule strength is required,

• a personalised amount of active ingredient is prescribed,

• the patient needs a capsule form rather than another dosage form,

• a formulation needs to be adjusted to the patient’s individual requirements,

• the prescribed preparation is not available as a standard commercial option.

Every case is assessed individually. The preparation is made only when there is an appropriate prescription or instruction, and only when the pharmacist confirms that the formulation can be prepared properly in the pharmacy laboratory.

Quality starts with the right laboratory

Preparing capsules is a precise pharmaceutical process. It is not simply a matter of placing powder into empty capsules.

In our galenic pharmacy laboratory, we focus on:

• clean and organised laboratory conditions,

• suitable professional equipment,

• accurate weighing,

• correct selection of excipients,

• homogeneous powder mixing,

• consistent capsule filling,

• proper capsule closing,

• visual quality checks,

• correct packaging and labelling,

• traceable and documented preparation procedures.

Each step matters because the quality of the final capsule depends on accuracy, consistency and controlled handling.

Professional capsule filling equipment

For capsule preparation, we use professional capsule-filling equipment designed for pharmacy compounding.

A capsule filling machine helps the pharmacist prepare capsules in a more consistent and controlled way. It supports the correct positioning of empty capsules, separation of capsule bodies and caps, uniform distribution of powder and proper closing of the finished capsules.

Professional capsule filling equipment can help improve:

• workflow efficiency,

• powder distribution,

• capsule alignment,

• batch consistency,

• handling of different capsule sizes,

• reduction of powder loss,

• repeatability of the compounding process.

The FagronLab™ FG system is a semi-automatic manual capsule filling machine designed for pharmacy laboratories. It can be used with hard-shell capsules in different sizes, including sizes 00, 0, 1, 2, 3 and 4, depending on the required formulation and capsule volume.

Useful link:
https://www.fagronlab.com/content/40/fagronlab-fg

Why excipients matter in compounded capsules

In capsule compounding, the active ingredient is only one part of the formulation. Excipients are often needed to help achieve the correct capsule volume, improve powder flow and support the technical quality of the final preparation.

The choice of excipient should not be random. The pharmacist must consider the nature of the active ingredient, the dose, the capsule size, the powder characteristics and the intended formulation.

A suitable capsule powder base can help with:

• better powder flow,

• more consistent filling,

• improved powder handling,

• appropriate capsule volume,

• formulation reliability,

• technical quality of the compounded preparation.

Using Fagron DiluCap as a capsule powder base

Fagron has developed DiluCap, a line of excipients specifically designed for hard-shell capsules in pharmaceutical compounding.

DiluCap excipients are intended to support pharmacists in preparing capsule formulations with greater confidence in the final technical characteristics of the preparation. They are designed to help with the challenges of capsule compounding, such as powder flow, compatibility, filling behaviour and formulation performance.

Useful links:
https://fagron.com/brands-v2/dilucap/
https://fagron.com/news-media/post/dilucap-a-complete-line-of-excipients-for-hard-shell-capsules/

In our pharmacy laboratory, the choice of capsule base or excipient is made by the pharmacist according to the prescription, the formulation requirements and the characteristics of the powders used.

How compounded capsules are prepared step by step

Below is a clear overview of how capsules are typically prepared in a pharmacy compounding laboratory.

1. Prescription review

The process begins with a careful review of the medical prescription or therapeutic instruction.

The pharmacist checks:

• the patient details,

• the prescribed active ingredient or ingredients,

• the amount required per capsule,

• the total number of capsules to be prepared,

• the dosage instructions,

• any special requirements for preparation, packaging or storage.

If anything is unclear, the pharmacist may contact the prescriber for clarification before proceeding.

2. Formula assessment and calculations

The pharmacist calculates the total quantity of each ingredient required.

This includes:

• the active ingredient,

• the excipient or capsule powder base,

• the total batch size,

• any overage or process-related quantity needed according to the laboratory procedure,

• the suitable capsule size.

This step is essential because accurate calculations are the foundation of a safe and consistent preparation.

3. Capsule size selection

The capsule size is selected based on the total powder volume and the physical properties of the powder mixture.

Common hard-shell capsule sizes include 00, 0, 1, 2, 3 and 4. The selected size must be appropriate for the prescribed dose and the required amount of excipient.

The aim is to achieve a capsule that can be filled properly, closed securely and used comfortably by the patient.

4. Preparation of equipment and workspace

Before compounding begins, the pharmacist prepares the working area and the equipment.

This includes:

• cleaning the work surface,

• checking that the capsule filling machine is clean and dry,

• selecting the correct capsule-size parts,

• preparing the powder tray, tamper and spreading tools,

• ensuring that all materials are ready and identified.

A clean and organised workspace reduces the risk of errors and supports consistent quality.

5. Accurate weighing

The active ingredient and excipients are weighed using an appropriate analytical balance.

Accurate weighing is one of the most important stages of capsule compounding. Even small errors in weighing can affect the final preparation.

Each ingredient is checked before use, and the quantities are handled according to the laboratory’s internal quality procedures.

6. Powder blending

The weighed powders are blended carefully to achieve a homogeneous mixture.

Homogeneous mixing is essential because the active ingredient must be evenly distributed throughout the powder blend before the capsules are filled.

The pharmacist may use geometric dilution or another appropriate mixing technique, depending on the quantity of active ingredient and the characteristics of the powders.

7. Loading empty capsules into the capsule filling machine

Empty hard-shell capsules are placed into the capsule filling machine.

The equipment helps orient the capsules correctly and separate the capsule bodies from the caps. The capsule bodies remain in the filling section, while the caps are held separately for closing later.

Correct capsule orientation is important for efficient and clean filling.

8. Filling the capsules with powder

The prepared powder blend is placed onto the powder tray and spread evenly across the capsule bodies.

Using the spreading tools, the powder is distributed carefully so that each capsule body is filled as uniformly as possible.

Depending on the powder properties, the pharmacist may use gentle tapping or tamping to help the powder settle into the capsules. Additional powder may then be spread again until the required filling is achieved.

This is one of the most important technical stages of the process.

9. Tamping and levelling

Tamping helps compact the powder inside the capsule bodies when needed. It can improve the filling of powders that are light, fluffy or difficult to settle.

After tamping, the remaining powder is spread again to complete the filling process. The pharmacist ensures that the powder is distributed as evenly as possible across all capsules.

The goal is to achieve consistency across the batch.

10. Closing the capsules

Once the capsule bodies have been filled, the caps are repositioned and the machine is used to close the capsules securely.

A properly closed capsule should remain intact, clean and stable during handling and packaging.

11. Cleaning after preparation

After the capsules are prepared, the equipment and workspace are cleaned carefully.

Cleaning is an essential part of quality assurance. It helps prevent cross-contamination and ensures that the equipment is ready for the next preparation.

Our commitment to quality in capsule compounding

In our pharmacy laboratory, compounded capsules are prepared with attention to detail, professional responsibility and respect for the medical prescription.

We focus on:

• accurate prescription execution,

• suitable capsule filling equipment,

• reliable capsule excipients,

• clean laboratory practice,

• careful weighing and mixing,

• controlled filling and closing,

• appropriate packaging and labelling,

• patient-specific pharmaceutical care.

Our aim is to provide a personalised pharmacy service that combines the knowledge of the pharmacist with the needs identified by the prescriber.

If you have a prescription for compounded capsules, you can contact our pharmacy team to discuss whether the preparation can be made in our galenic laboratory.