Top 12 Consideration for Children’s Capsule Making

1.What is children's capsule making?

Children’s capsule making-   Picture courtesy: Momjunction

In the pharmaceutics and clinical sciences, when formulating capsules, the main focus is always on active pharmaceutical ingredients and their specific dosage. The development of children’s capsule making requires specific challenges to determine the dosage requirements, clinical efficacy, and side effects.

Children’s capsule making is an important method that assures you the safe dose is reached to children without triggering any potential side effects.

This is an important field of manufacturing as it meets many more challenges than adults do. The major point is the lack of research in determining the safe dose for children. Also, children require more specific formulation as it needs to improve with more taste masking, small in sizes, and related factors that can result in comparable higher cost.

2.What is the top 12consideration for children's capsule making?

When designing a protocol for children’s capsule making. There are the following considerations that are required for every manufacturer.

Understanding the Nature of Active Pharmaceutical Ingredients

Nature of Active Pharmaceutical Ingredients- Picture courtesy: Children’s health

Children's dosages are mainly designed in an oral liquid formulation, although many APIs become degraded in the gastric environment. To protect the doses, children's capsule making is required.

Many types of active pharmaceutical ingredients are exerting their action at specified dosage concentrations. They’re mostly needed to be added in milligrams or micrograms.

Therefore, understanding the safe and potent concentration should be used. In the case of children, the dose concentration you use for adult capsules is not the same. It is all about depending on the weight and age of the specific group. Moreover, in many cases, you will need to add inactive ingredients such as diluents, and filler to produce a convenient dose response.

3.Design to ensure ease of Swallowing

Ensure ease of Swallowing- Picture courtesy: Randox laboratories

A big capsule for children looks scary. Not in the term of taking medication but swallowing is also very difficult for tiny throats. Therefore, children’s capsule making must be done in a way to generates the correct dose.

The capsule dose size is not always fit for all treatments or scenarios. To create an easy swallowing capsule making size must be standard otherwise larger capsules have negative effects on the acceptability of the medication as it will look scary to kids.

4.Understanding sizes in empty capsules for children

Sizes in empty capsules for children- Picture courtesy: Healio

The empty capsules provide ranges for children's medicines. They are used for the encapsulation of health-related supplements. They offer you broad size ranges that are commonly used in today’s industry. You need to properly understand the size chart for picking the smart choice. For that, check the mentioned chart below:

	From large to small	Weight in mg May vary depending on powder flowability (Density)			Volume	Locked Length
	000	Light	Medium	Heavy	ml	mm
		615	960	1370	1.37	26.14
	00	430	665	950	0.95	23.30
	0	305	475	680	0.68	21.70
	1	225	350	500	0.5	19.40
	2	165	260	370	0.37	18.00
	3	135	210	300	0.30	15.90
	4	95	145	210	0.210	14.30
	5	60	90	130	0.130	11.10

Capsule size chart

After observing the table’s value, you can see the largest capsule size is 000 whereas going toward making the value small and smaller. Capsule 5 has the smallest size. Therefore, choosing the right capsule size is very important and for that, you have to consider the following objectives:

The capacity of the capsule which is mainly addresses the mass and volume of the material to be filled inside. This is mainly expressed in milligrams for every dose. You can call it the density, for your understanding, the chart is also expressing the density of the material. Density = Mass (g) / Volume (ml).

Knowing about the material’s density, it would be now very easy for you to estimate the required children capsule making dosage for you and the right type of capsule size that can fill the material without worrying about overcapacity or underfilling.

5.Selecting the suitable size of children’s capsule

Children capsule size- Picture courtesy: Capscanada

To ensure children’s capsule making is suitable for kids. The ideal size ranges in between 2, 3, 4, and 5. The larger than these sizes are not recommended for children. Most often, the children face challenges in swallowing big-size capsules. These children’s capsule making is mostly required for the administration of vitamins, probiotics, or supplements.

The size ‘2’ is commonly used for this purpose which offers a length of 17.6 mm with a volume of 0.36 ml. The common filling capacities in size ‘2’ capsules are noted as 216 to 430 mg, which is equal to taking 0.04 to 0.08 of teaspoon. Moreover, along with solid powders, the liquid formulation is also used in this size which is of course smaller in concentration.

6.Which is best: gelatin capsule or vegetarian capsule for children?

Gelatin capsule or vegetarian capsule for children- Picture courtesy: Albany ENT

You need to evaluate the type of formulation you intend to prepare for children’s capsule making. There are two basic types of capsules, gelatin and plant based or vegetarian capsules. Gelatin is sourced from animals conversely plant-based sources are also used to make vegetarian capsules. Every parent wants their children to consume plant-based capsules for many reasons such as safety, dietary restriction and so much more.

Choosing gelatin capsules for children

Gelatin capsules for children

Anyhow, the answer is all about based on your production demand. For example, if you are making any therapeutic medication then the best choice for this purpose is gelatin capsules. Many pharmaceutical companies also prefer using gelatin capsules for their dosage formulation.

Many medicines are sensitive to oxidation processes; therefore, pharma-based drug is encapsulated in gelatin capsules to prevent them from rapid oxidation reactions.

In other cases, if your medicine is hygroscopic in nature, vegetarian capsules are considered as suitable for this purpose, the children’s capsule making can be done by using vegetarian capsules.

Choosing vegetarian capsules

Vegetarian capsules

In the case of supplement encapsulation, nutraceutical companies mostly prefer using vegetarian capsules for children’s capsule making. This is indeed the first choice. Because it is not only a natural product but also shows high inclination and market demand. Therefore, the high trend for these capsules ultimately makes them the first choice for health-related supplements for children’s consumption.

7.Considering the taste for children’s capsule making

Taste for children’s capsule

Many of the health-related supplements as well as therapeutic medication smell weird. Children straight refuse to take them. Not only children but adults also don’t prefer taking capsules with unpleasant smell or taste.

This is very important for you when planning for children's capsule making that the formulation should be pleasant and has the property of taste masking. Other it tastes weird, believe me, it won't be worth formulating the more and more batches.

Therefore, you must design the capsule by coating the ingredients in microencapsulation. In this way, your capsule's ingredients would not only be safe from the gastric environment, but it will directly reach specifically to the target side.

Also, in this way, you can coat the material with fruity flavors. For example, oranges, strawberries, lemon, bubble gum, etc. It will help to make the capsules more acceptable to children and make them safe from stomach secretions too.

8.Using appealing ways for children capsule making

Attractive presentation- Picture courtesy: capsuline

Children love colors, flavor, and the attractive appearance of things. When you offer the capsules to a child that are absolutely customized in presentation and made up of vibrant colors; they would seldom refuse to take them.

For children’s capsule making, you will need to coat the capsules with vibrant colors. For that, you use either:

Standard coating pan

The conventional mode of coating where a coating pan carries the bed of capsules and a spray nozzle can burst the even coating particles application.

Perforated coating pan

This is also similar to a standard coating pan except it is composed of a perforated plate or a perforated drum which ensures coating as well as easy drying of the coating materials.

Fluidized coating pan

This is an extensive machine that uses the fluidized mechanism for the coating and drying of the capsules. The capsules move upward in a fluidized form with the help of hot air, in this state, the coating spray is applied over the fluidized capsules followed by drying.

These units help in increasing an individual’s compliance with capsules and make a child love their customized medicines.

9.Focusing on the particular age

Focusing on the particular age- Picture courtesy: Amen clinic

As we already mentioned above swallowing issues can be the major concern behind the children's capsule capsule-making process. Therefore, when manufacturing the capsules you should better be focusing the specific age group. For example, the capsule medications should be designed for 4 years plus children. At this age, they seem very understanding about medication and motivated to know the reasons for taking it.

10.Premium standards ingredients

Premium standards ingredients- Picture courtesy: Childlife NZ

Your capsule formulation should be compliant with health and international safety regulations. It protocol must be genuinely safe and hygienic for children. You should know that entire ingredients used for children's capsules are majorly natural and non-toxic in any way. This is what your expertise matters.

The capsules you use (gelatin or vegetarian) should be made up of superior-quality elements. Therefore, you can offer your customers extraordinary products. The ingredients must be free from preservatives, and free from allergens.

11.Highlighting the detailed label

Highlighting the detailed label

The children's capsule packing must be done with extra care and monitoring. The labeling should be promising enough in terms of offering details about the dosing information, age, weight, and dosage instructions.

Additionally, the method for administering the capsules, precautions, side effects, and dose per age, all relevant and mandatory information should be properly mentioned.

12.Packaging requirements

Packaging requirements- Picture courtesy: sinakala

As we know children's capsule making is mostly associated with health-related supplements and symptomatic treatments. Therefore whether you are using gelatine capsules or vegetarian capsules, the packaging should be done in a way that resists the interaction of physical factors such as light, moisture, air, etc.

This means the packaging must be airtight with the proper placement of a desiccator to minimize the chances of moisture inside. The packaging bottles or the material of the container must be resistant to light absorption so photodegradation can be stopped or minimized.

13.Challenges

Challenges- Picture courtesy: Neurofen

Nevertheless, the children's capsule making process is a challenging procedure. Along with focusing on the medication, therapeutic index, potency, and side effects, you also need to manage the challenges. There are certain points you should consider when considering children’s capsule making.

Accessing the medication

This is a challenging factor for every manufacturer to produce capsules that can't be reached or accessed by children.

Solution

There is a specific type of packaging which is known as child-resistant packaging is a new innovation in the pharmaceutical sciences that ensures that child-resistant packaging can't or opened or accessed by young kids. The child-resistant packaging also known as CR packaging presented with modern caps or closures making children difficult to open the lids. In this way, there is almost less chance of overdose or children accidental ingestion.

In the case of blister packaging, refers to the puncture-resistant capsules picking or peel push blister that ensure children’s safety.

Risk of choking

When it comes to taking oral medication, for children there are high risks of choking. It can be due to large capsule size, or pressure to take medication. This issue ultimately causes a high risk of choking.

Solution

To avoid this problem, there are certain points you should know; For example:

• Children’s capsule making products must be restricted to ages 4 and above. Moreover, the parents should also not force the children to take the capsule. Secondly, the manufacturer must mention the precautionary statement on the label of the capsules which should clearly mention the product is not recommended for children below the age of 4 years because children are more prone to choke when they are administering it.
• This is also the responsibility of the manufacturer to mention that the capsules must be administered under adult supervision.

Conclusion

Children’s capsule making always requires a critical evaluation and extra care. As children need accurate dosage and there’s a lack of research on it. After reading a blog on ‘ Top 12 Considerations for Children’s Capsule Making’ we hope you have found basic ideas and age-specific requirements. If you have any questions or want to know about capsule making machines for starting a business related to children’s capsule making, contact AIPAK’s experts. We are a qualified team in providing equipment used in capsule making and packaging. Why not try us? Please contact us now to avail detailed information related to machines and finding answers to your query.