Samarth Institute of Pharmacy, Belhe, Maharashtra, India
The most sensible, safest, and natural way to take medication is through the mouth. An overview of the most recent materials and technologies utilized to address issues with patient compliance, pharmaceutical release, absorption, and overall efficacy will be given in this article. Because of their superior patient compliance, portability, stability, and convenience of handling, tablets are the most often used solid oral dose form. Over time, tableting technology has made considerable advancements. This work seeks to shed light on advancements in tablet excipients, production procedures, analytical methods, and the use of Quality by Design. The term "dosage form" describes the physical shape of a medication, such as a solid, liquid, or gas, that enables proper administration to certain body sections. Manufacturing has also benefited from co-processed multifunctional ready-to-use excipients with shorter processing periods, especially for tablet dosage forms. To enhance the performance of products and processes, new advancements in granulation techniques have been created, such as reverse wet, thermal adhesion, steam, melt, freeze, foam, and moist and pneumatic dry granulation. Additionally, a variety of particle engineering methods, such as co-precipitation, hotmelt extrusion, extrusion-spherization, have been used to create robust tablet formulations.
Conventional dosage forms remain the most widely used and have a firm hold in all types of pharmaceutical preparations meant for oral use, even in this age of innovation and improvement in drug delivery for improved therapeutic outcomes. [1]. Tablet doses form have integrated automation in manufacturing and several sophisticated tablet kinds to meet the demands of the expanding market. Because of its durability and patient acceptance, the tablet is the most often utilized dosage form among all those available. In 2014,. Film and sugar coatings were necessary for improved aesthetic qualities including color, texture, tongue feel, and flavor masking; so, the coating plays a crucial role in the tablet's composition. [2]. A drug's dosage form is its physical shape, such as a solid, liquid, or gas, that allows it to be administered to specific body areas in its appropriate form. This section presents a pharmaceutical study of completed solid oral dosage forms from the perspective of what makes the delivery form special and effective—that is, the physical characteristics and drug substance's condition in the matrix. Polymeric pharmaceutical excipients enable hiding undesirable physicochemical features of pharmaceuticals and, as a result, modifying their pharmacokinetic profiles to improve the therapeutic impact when packaging difficult compounds into solid oral dosage forms. [3]. Consequently, there are now a plethora of synthetic and natural polymers that may be purchased commercially as pharmaceutical excipients, providing possible answers to a range of issues. For example, the various polymers may provide enhanced solubility, shellability, viscosity, biodegradability, sophisticated coatings, cohesion, pH dependence, and crystallization inhibition. This article's goal is to present a comprehensive overview of the many applications of pharmaceutical polymers in solid oral dosage forms. [4].
Fig. 1 [52].
Types-
A particular kind of layer tablet made up of precisely two layers is called a bilayer tablet. varied active pharmaceutical ingredients (APIs) or the same API with varied release characteristics might be included in each layer. [5-9]. This design offers enhanced control over drug delivery compared to single-layer tablets.
Fig.2 [53].
Key Characteristics of Bilayer Tablets
Benefits of Bilayer Tablets
Mini tablets are scaled-down versions of regular tablets, with screens that normally measure between 7 and 8 inches. They put mobility and convenience first without compromising on necessary functionality. [11].
Fig.3 [54].
Key Characteristics
Compact size:
Affordable:
Benefit
Orally disintegrating tablets (ODTs), sometimes referred to as mouth dissolving tablets or fast-melting tablets, are a kind of dosage form that dissolves quickly in the mouth without the need for water. They provide a practical and effective means of giving medication, particularly to individuals who have trouble swallowing. [12].
Fig.4 [55].
Common excipients include
These substances accelerate the breakdown of the tablet.
Improve taste and palatability.
Enhance the overall sensory experience.
A Cutting-Edge Medication Administration Method One portion of an inlay tablet is covered while the other is revealed, making it a special kind of layered tablet. With this design, many drug release characteristics may be combined into one dosage form. [14].
Fig.5 [56].
Benefits
Combining immediate-release and sustained-release antidiabetic drugs.
Combining fast-acting pain relievers with long-acting analgesics.
Delivering different drugs for heart conditions.
A tablet having many separate layers, each containing various active pharmaceutical ingredients (APIs) or the same API with varied release patterns, is called a layer tablet. With this design, a single tablet can have immediate-release, delayed-release, or sustained-release qualities for customized medication administration.[15].
Fig.6 [57].
Key Characteristics of Layer Tablets
Can consist of two or more layers.
Each layer may contain different active ingredients.
Layers can have immediate, delayed, or sustained release characteristics.
Reduces the number of pills needed, enhancing adherence.
Benefits of Layer Tablets
Precise control over drug release timing and rate.
Fewer pills to take throughout the day.
By combining different drug actions, better treatment outcomes can be achieved.
Can reduce production costs compared to separate tablets. [16].
Clinicaps are a type of empty gelatin capsule specifically designed for use in clinical trials. They are characterized by:
Similar to standard gelatin capsules but with a tighter fit.
The elongated cap locks tightly onto the body, making it difficult to open without leaving visible evidence.
Designed for easier swallowing.
Why use Clinicaps?
Double-blind studies:
They effectively conceal the contents, ensuring that neither the patient nor the researcher knows whether a capsule contains the active drug or a placebo.
Prevention of tampering: The tight closure helps maintain the integrity of the study medication. Essentially, Clinicaps are a crucial tool in conducting fair and accurate clinical trials.
Fig.7 [58].
Pastilles are small, solid pieces of confectionery or medication designed to be slowly dissolved in the mouth. They are often associated with soothing sore throats or freshening breath.
Types of Pastilles
Medicated pastilles:
Contain active ingredients to treat specific conditions, such as sore throats, coughs, or allergies.
Sweet pastilles:
Enjoyed for their flavor and texture, often containing sugar or artificial sweeteners.
Fig.8 [59].
Key Characteristics
Typically, round or oval-shaped.
Designed to be slowly dissolved in the mouth, releasing flavor or medication gradually.
Available in a wide range of flavors to suit different preferences.
Common Uses
Medicated pastilles can soothe irritation.
Some pastilles contain ingredients to suppress coughs.
Sweet pastilles can help freshen breath.
Sweet pastilles are often consumed as a treat.
3,4-methylenedioxy-methamphetamine (MDMA) a psychoactive substance mostly used for its euphoric and empathogenetic effects, belonging to the groups of medications known as substituted methylenedioxy-phenethylamine and amphetamine. Pharmacologically, MDMA functions as a reuptake inhibitor and a serotonin-norepinephrine-dopamine releasing agent. [17]. Commonly used to refer to MDMA in tablet form, "Ecstasy" may also refer to the presence of potential adulterants. MDMA in the form of crystalline powder free of adulterants, such as "molly" in the US and "Mandy" in the UK. MDMA possession is prohibited in the majority of nations. There are a few specific exclusions for scientific and medical research. In certain mental diseases, MDMA may be beneficial to health; nevertheless, it can also have negative consequences, such as neurotoxicity and cognitive impairment.
Fig.9 [60].
Gummy bears are beloved for their chewy texture and fruity flavors. These small, bear-shaped candies are a popular treat enjoyed by people of all ages.
Key Characteristics
Soft and pliable.
Often come in a variety of fruit-inspired tastes.
Vibrant colors make them visually appealing.
Traditionally made with gelatin, though vegetarian alternatives are available.
Fig.10 [61].
Ingredients
Typical ingredients in gummy bears include:
Provides the chewy texture (or a vegetarian alternative like pectin).
Sweetens the candy.
Adds moisture and texture.
Provides the fruity taste.
Creates the vibrant colors.
Gives the candy a tangy flavor.
Lollipop Lozenges:
Sweet Relief Lollipop lozenges are essentially throat lozenges in the delightful form of a lollipop. They combine the soothing properties of traditional lozenges with the fun and enjoyment of a lollipop. [18].
Key Features
Often come in a variety of fruity or menthol flavors.
Help to alleviate sore throats, coughs, and other throat discomforts.
The lollipop format allows for extended contact with the throat.
Especially appealing to children. [19-22].
Fig.11 [62].
Benefits
Provide targeted relief for throat irritation.
The lollipop form makes medication more enjoyable for kids.
Helps keep the throat moist.
Easy to carry and consume.
Fig.12 [63].
Recent Advances in oral solid dosage forms-
New Technological Advancements in Solid Oral Dosage Forms-
The field of pharmaceutical technology is constantly evolving, with a particular focus on improving the efficacy, safety, and convenience of solid oral dosage forms. Here are some of the most promising advancements [23-25].
1. 3D Printing Technology
Personalized medicine:
Allows for the creation of customized dosages and formulations based on individual patient needs. Complex medication delivery systems: Make it possible to create tablets with several layers or components and precise drug release characteristics.
Enhanced bioavailability:
By maximizing the features of medication release, this can improve drug absorption. Additive manufacturing, also referred to as 3D printing, is transforming the pharmaceutical sector by providing previously unheard-of flexibility in the creation of solid dosage forms. [26].
Fig.13 [64].
Challenges and Future Directions
Ensuring that printing materials are biocompatible and suitable for drug delivery.
Developing efficient and cost-effective processes for large-scale production.
Obtaining necessary approvals for 3D-printed drugs.
Protecting innovative 3D-printed dosage form designs.
Fig.14 [65].
2. Nanotechnology
Improved medication delivery: Drug solubility, bioavailability, and targeting can all be enhanced by nanoparticles. Controlled release: Allows for longer or more gradual medication release for more effective treatment. Increased stability: Prevents medication deterioration during production and storage. [31]. Solid dosage forms with intricate drug delivery mechanisms are a major development in pharmaceutical science. These methods seek to address issues with conventional dosage forms, including inadequate therapeutic results, restricted drug targeting, and low bioavailability. [32-35].
Fig.15 [66].
Types of Complex Drug Delivery Systems
Controlled Release Systems:
These systems deliver the drug at a predetermined rate over an extended period.
Matrix systems:
The drug is dispersed within a polymeric matrix.
Coated systems:
The drug is coated with a polymeric material that controls drug release.
Osmotic systems:
The drug is released through an osmotic pressure-driven mechanism Nanotechnology has revolutionized the pharmaceutical industry, particularly in the development of solid dosage forms. By manipulating matter at the nanoscale, scientists have been able to create innovative drug delivery systems with enhanced efficacy and safety.
Key Applications of Nanotechnology in Solid Dosage Forms
Many drugs have poor water solubility, limiting their bioavailability. Nanotechnology can address this by reducing particle size to the nanoscale, increasing the surface area, and improving dissolution rate. [36].
Nanoparticles can be engineered to release drugs at a controlled rate, extending drug action and reducing dosing frequency.
By attaching specific ligands to nanoparticles, drugs can be targeted to specific cells or tissues,
Lipid-based nanoparticles that provide a stable matrix for drug encapsulation.
Drug particles reduced to the nanoscale to improve solubility and dissolution rate.
Challenges and Future Directions
While nanotechnology offers significant advantages, there are also challenges to overcome, such as:
Producing nanoparticles in large quantities while maintaining consistent quality can be difficult. [37-38].
Ensuring the safety of nanoparticles for human use is crucial.
Navigating the regulatory landscape for nanotechnology-based drugs can be complex. Despite these challenges, the potential benefits of nanotechnology in solid dosage forms are immense, and ongoing research is focused on addressing these issues and translating nanotechnology into clinical applications.
3. Digital Pill Technologies
Incorporates sensors and tracking mechanisms to monitor drug intake and provide real-time data.
Enables authentication and verification of drug authenticity.
Collects data on drug efficacy and safety to optimize treatment plans. Digital pills, also known as smart pills or ingestible sensors, represent a significant advancement in drug delivery and patient care. [39].
Improved Medication Adherence:
By tracking medication intake, digital pills can help patients and healthcare providers identify patterns of non-adherence and develop strategies to improve compliance.
Real-time data on medication use allows for more personalized treatment plans and timely interventions.
Digital pills can provide valuable data for drug development and efficacy studies.
Fig.16 [67].
Challenges and Future Directions
While digital pills hold great promise, there are challenges to overcome, such as:
Ensuring the secure handling and protection of patient data is crucial.
The technology may be expensive for some patients and healthcare systems.
Overcoming concerns about privacy and the added complexity of using a wearable device. Despite these challenges, the potential benefits of digital pills are substantial, and ongoing research and development are focused on addressing these issues and expanding the applications of this technology. [40].
Improved drug delivery:
New excipients with specific functionalities enhance drug release, solubility, and stability.
Excipients can improve taste, texture, and overall acceptability of dosage forms. The Unsung Heroes of Drug Delivery Excipients, often overlooked, play a critical role in the formulation and performance of solid dosage forms. Recent advancements in excipient technology have led to the development of innovative excipients that enhance drug delivery, improve product stability, and enhance patient experience.
Types of Advanced Excipients
These are pre-blended combinations of multiple excipients, offering improved functionality and processability. [41-43]. For example, a combination of a binder and a disintegrant can enhance tablet disintegration while ensuring good tablet strength.
These polymers possess specific properties that can be tailored to meet specific formulation needs. For instance, hydrophilic polymers can improve drug solubility, while hydrophobic polymers can be used for controlled release formulations.
These excipients can enhance drug solubility, bioavailability, and taste masking. They are widely used in self-emulsifying drug delivery systems (SEDDS) and solid lipid nanoparticles (SLNs).
Advances in taste masking technology have led to the development of sweeteners and flavorings that can effectively mask the unpleasant taste of drugs, improving patient compliance. [44].
Benefits of Advanced Excipients
Enhance drug solubility, bioavailability, and release profile.
Protect drugs from degradation and extend shelf life.
Enhance taste, texture, and overall acceptability of dosage forms.
Reduce process steps and improve manufacturing efficiency.
Challenges and Future Directions
AI-driven process control can enhance efficiency and product quality. [46-47].
Predictive modeling:
Applications of AI in Solid Dosage Form
Formulation Development:
AI Techniques Used in Solid Dosage Form
Used for pattern recognition, prediction, and classification tasks.
For complex data analysis and image recognition.
For extracting information from scientific literature and patents.
Challenges and Future Directions
While AI offers immense potential, challenges such as data quality, model interpretability, and regulatory considerations need to be addressed. Future research should focus on developing robust AI models that can handle complex pharmaceutical data and integrating AI seamlessly into the drug development process. [50].
CONCLUSION:
These advanced oral dosage form formulations provide the medical community and patients a number of significant benefits. Customers may be satisfied if newly developed tablets are able to suit patient requests and the growing pharmaceutical sector. Their significant contributions have resulted in production advancements for tablets as well as a number of distinctive tablet adaptations that have made a strong market presence. Formulation experts are always attempting to create improved dosage forms, which will eventually benefit the healthcare system, on a global scale. Process analysis techniques and quality by design have been used..
ACKNOWLEDGEMENT
We would like to acknowledge and express our profound thanks to Dr. Bhalekar, S.M. for enabling our endeavor. Her guidance and instruction enabled me to finish every stage of writing my paper. We thank our institute for giving us the opportunity to carry out this review.
REFERENCES:
Kale Megha K., Wagh Snehal A., Walunj Ankita A., Dhage Shubhangi S., Awari Monika S., Bhalekar S. M. Lamkhade. G. J. , Recent Advances In Oral Solid Dosage Form Formulation And Development, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 10, 1075-1091. https://doi.org/10.5281/zenodo.13955626
10.5281/zenodo.13955626
