In the process of making drugs, there is a lot that needs to be handled. And as a manufacturer, having your finger on the pulse at all times will be important if you hope to make something that your consumers will find very useful.
Making your drugs alone isn’t just good enough – you need to also ensure that they’re properly coated and wrapped right. And for that, you generally have to choose between film and sugar coatings. This article will dive into the differences between the two, as well as how best to make a decision
Film Coating: Understanding the Process and Characteristics
This might be a focus on traditional pharmaceuticals, but the truth is that film coating is actually useful across multiple industries. From food manufacturing to drug making and more, film coating operates as a process where a thin layer of a coating material is applied onto the direct surface of a substrate – in this case, tablets.
The purpose of film coating is to provide protection for most medications. It helps to avoid pharmaceutical contamination, while also enhancing the drug’s appearance, taste, and ingredient release.
In general, the uses of film coating can majorly be split into the following:
Protecting Drugs: Film coatings offer a protective barrier that will shield your medication from any environmental factor – light, moisture, air, and all – thus ensuring that its quality is maintained.
Optimizing Appearance: At the same time, film coatings offer a better aesthetic appeal for your pills. They add gloss, color, and even elements of branding that make the drugs look more appealing.
Altering Traditional Taste: On their own, most drugs don’t necessarily taste good. Film coatings help to change this, masking the smell and taste of most drugs and making them more palatable.
Ensuring Modified Release: You can also engineer film coatings to essentially control the release of active ingredients from the dosage of the drug. This way, you can achieve a targeted release of the drugs inside the user’s body.
With a versatile process and a slew of applications, film coating has become a must-have in the pharmaceutical space.
Components of Film Coating Formulations
Like many things being used in the pharmaceutical space, there is a lot of variation when it comes to the components that actually make up film coating formulations. However, you can generally expect to find the following in the mix:
Polymers:
Everything else might be optional, but not polymers. These are the primary components of film coating formulations, and they mostly provide the properties that you see. As a drug manufacturer, you can have different polymers as part of your film coating formulations:
- Cellulose derivatives (such as hydroxypropyl methylcellulose and hydroxypropyl cellulose)
- Acrylic polymers (such as polyvinyl alcohol and polyacrylic acid)
- Gelatin
- Shellac
Etc.
Plasticizers
The plasticizers help to improve the general flexibility of your film coating. They also add durability to the mix, preventing issues like brittleness and cracking as the coating dries off.
From triacetin to diethyl phthalate and acetylated monoglycerides, you have a lot of plasticizers to consider here.
Solvents
In the mission to make a more uniform coating solution, solvents help to dissolve the entire polymer. You have different solvents available, from water and ethanol to acetone and more – generally, your choice will depend on the solubility of the polymer and the properties you need the coating to have.
Colorants
As you would imagine, these ones are added to the coating to provide the required appearance of the coated product. You can have des, pigments, or lakes – as long as they’ve been approved for use in medicinal purposes.
Opacifiers
The opacifiers help to make the coatings more opaque, ensuring that light is unable to pass through and protecting all of the light-sensitive substrates or ingredients. In most cases, you get talc and titanium dioxide as opacifier options.
Surfactants
You could also include surfactants as part of your coating formulation to help optimize spreading and wetting properties – while also cutting down on surface tension.
Flavoting & Sweeteners
These are the agents that help to mask any unpleasant scents or tastes of the capsules or tablets. This way, your medicines become easier to swallow.
Preservatives & Antioxidants
Finally, you have these additives, which help to optimize the stability of the film coated tablets and help them to last long by preventing the growth of microbes.
Sugar Coating: What Is It?
The other side of this coin is sugar coating. So, what does sugar coating mean?
Well basically, sugar coating is a more traditional method of coating, where tablets or capsules are coated with a sugar-based material to improve their look and taste. Interestingly enough, the sugar coating process is actually much older than film coating. But, it also works because it is versatile.
Apart from meds, you can find sugar-coated cake, and sugar coating candy has also become a popular manufacturing method in the confectionery space. So, it makes sense that drugs can become sugar-coated as well.
When it comes to sugar coating in the pharmaceutical space, you generally have to follow these steps:
- Start with subcoating, where you coat the tablets with an initial solution of cellulose derivatives or some other polymers.
- Then, place the tablets in a coating pan, where you apply multiple layers of syrup to them. In most cases, the syrup consists of a concentrated solution of sugar along with water and a few additives (glazing agents, colors, etc.)
- Once you apply the syrup, you leave the tablets to dry in the coating pan, so you can take out any excess moisture and properly combine the coating layers
- Finally, polish the tablets to improve the smoothness and gloss
The benefits of sugar coating are pretty much the same as film coating – it helps to improve the general appearance of the drugs, and it also masks the taste and makes them last longer. So, both are pretty much interchangeable – although, as we’ll see later, there can be variations between them.
Components of Sugar Coating Formulations
One of the major differences between film and sugar coating lies in the components of their formulations. We already know the sugar coating definition, so what are the components that lie in these regular coating builds?
Sucrose
Well, you can’t have sugar without sucrose. Just as you have polymers for film coating, you have sucrose for sugar coating. It provides both sweetness and primary coating, ensuring that your tablets are properly held together.
Water
You also need water for sugar coating. It is the primary solvent, dissolving both the sugar and any additional additives and forming a syrup that allows you to properly coat the tablets. Now, it’s important to be careful here, as the amount of water you use will most likely affect the viscosity and drying time of the solution.
Colorants
As expected, these ones help to provide the desired appearance and color for the tablets. You can have both natural and synthetic dyes, as long as they are cleared for pharmaceutical use.
Flavoring Agents
If the sucrose doesn’t do a good enough job of masking the unpleasant taste of the medications, then you can add extra flavoring agents to the mix. Natural and artificial flavors are available to you, so you have your pick.
Glazing Agents
Also an aesthetic component, glazing agents help to improve the smoothness and gloss of the sugar-coated tablets. Shellac, waxes, and synthetic polymers are some of the top options here.
Film-forming Agents
In some sugar coating formulations, you also get film-forming agents that help to optimize the durability and adhesion characteristics of the sugar coating itself. Thanks to these agents, you can prevent things like cracking or chipping in your medicines, especially as the coating process goes on.
Opacifiers
If your sugar coating needs to be opaque, then an opacifier is a pretty solid option to have. It ensures that light doesn’t pass through the tablet, and that all light-sensitive components are properly protected.
Binders:
When you apply sugar coating to a tablet, you usually need binders to also improve the general adhesion of the coating to the core of the tablet. These binders ensure that the coating is evenly distributed, and that it doesn’t end up flaking or peeling off.
Film Coating vs. Sugar Coating: A Detailed Comparison
Sugar Coated Pills Film Coated PillsNow that we’re aware of what film coating is and we’ve gone through the question of “what is sugar coating?” let’s now look into the two options to better understand what they are and the lines of distinction between them.
The Composition Of The Coating Formulations
We already looked into this, so there’s no point dwelling so much. With film coating, you work with polymers, plasticizers, solvents, and more. On the other hand, sugar coating mostly brings in sucrose, water, glazing agents, colorants, and others.
General Tablet Appearance
Tablets that have been film-coated tend to have a smooth, glossy appearance with a more uniform distribution of color. At the same time, you can customize them to fit different colors, and you can even print your logos and marks on them.
Sugar-coated drugs tend to come with a shiny appearance. They tend to be thicker, though, so the tablets look a bit bulkier. The demerit of this, of course, is that the medicines might not be so easy to swallow overall.
How Do They Taste?
One of the major points of coating in the first palace is to improve the taste of the tablet. For film coating, the tablets usually don’t have any smell or taste associated with the coating itself. However, sugar coating makes your tablets sweeter – due to the sugar content available in the coating, of course.
If taste is a huge factor for you, then sugar coating most likely will be the top pick.
The Process Of Making Them
In film coating, you essentially spray the coating on the surface of the tablet with specialized equipment. Then, let it dry, so you get a thin, continuous film.
Sugar coating, on the other hand, is a more labor-intensive process that involves everything from subcoating to polishing to sugar coating and more. It takes much more to be done, but as you can imagine, the results speak for themselves.
Maintaining Stability & Protection
Film coatings tend to offer a strong protective barrier that shields the core of the tablet from factors like light and moisture, thus ensuring that it doesn’t get degraded overall.
Interestingly, sugar coating actually does a better job of protecting your drugs from air and moisture. However, when it comes to offering long-term stability – especially for drugs sensitive to moisture – you might find that sugar coating isn’t necessarily as effective.
The Durability & Flexibility Of The Mold
Film coatings are known to be pretty flexible. They can easily be placed on the surface of the tablet, and you won’t need to worry about cracking or chipping. Plus, they’re able to withstand transportation and handling, and you don’t need to worry about damage.
On the flip side, there’s a risk of cracking and chipping with sugar coatings – especially if you don’t apply them evenly enough. So, additional polishing might be needed to ensure that they look and feel better.
How Expensive Are They?
Because of the quicker drying times and the automated nature of the process, film coating processes tend to be more cost-efficient than sugar coating. You don’t need much labor, and your equipment requirements tend to be smaller as well. So, if cost is a major factor for you, film coating is probably what you want to focus on.
Film Coating vs Sugar Coating: Pros and Cons
So to recap everything we know about sugar-coated tablets and the film coating process, let’s run through the pros and cons of both:
Film Coating Pros vs Sugar Coating
- Generally, film-coated tablets tend to come with a smoother and more uniform appearance, so on the aesthetics front, they’re more more ideal
- You can also customize film-coated tablets as much as you want, whether to meet branding or marketing needs
- Their durability – especially compared with sugar-coated tablets – is more impressive.
- Thanks to their shape profiles, film-coated tablets tend to be easier to swallow and take in
- And, the fact that film coating tends to be more cost-effective overall should also be mentioned, especially for people who have cost as their major blocker.
Sugar Coating Pros vs Film Coating
- On the flip side, the sweet taste of sugar-coated medicines is a huge benefit. This makes them more palatable, especially for children who need to take the medicines
- The thick protective barrier you get from sugar coating ensures that it’s safe from moisture, air, and light
- You also get a lot of flexibility in design when it comes to sugar coating, making it easy ro meet specific branding requirements too.
- Thanks to the nostalgic and familiar feel, sugar coating comes with a specific traditional appeal that film coating might not be able to achieve
Which Method Is Better For Different Types Of Drugs?
With everything that’s been said, how do you now make a decision between film and sugar coating if you’re a drug manufacturer? Well, maybe some of these guidelines can help you out:
Start By Understanding What You Need
Before anything else, the requirements of the drug formulation come first. So, look into these specific requirements – from active ingredient properties to the release profile and more. Then, you can look at things like color, taste, and others.
Examine The Manufacturing Capabilities
Next, look into the tools and expertise available to you – this way, you can decide which of the coating methods to go for instead. Both have several lines of convergence, so knowing what is needed will be critical here.
What Do The Patients Need?
As a drug manufacturer, you need to remember that the patients’ needs come first. So, examine their requirements and preferences – especially when it comes to things like tablet taste, appearance, and swallowability.
Ensure Regulatory Compliance
Adherence to regulatory standards will be needed – remember that these are medications, and you need to be very careful with what you’re making for your patients. If there are restrictions to specific coating materials, then you might need to exclude them from your stack.
Always Consult With Experts
At the end of the day, it’s impossible to know it all. So, consult with experts to get their informed opinions and use their knowledge to your advantage.
Conclusion
Film and sugar coating have become two of the most popular coating formulations in the pharmaceutical space. Their efficiency, as well as their ability to protect your medicines, makes them a must-have for any drug maker.
At Sainty Tec, we can always help you with any resources or insights you need to make a decision. So, feel free to reach out to us.
