Loader
Please Wait
Applying Filters...

Douglas Pharmaceuticals Key Services Douglas Pharmaceuticals Key Services

X

Overview of oral solid dose (OSD) dosage manufacturing, specifically film coated tablets, complex modified release tablets & controlled substances.

Filters Filter
Cross PopUp
FILTER :

filter

01 Chewable / Suckable

02 Chewable / Suckable

03 Chewable / Suckable

04 Chewable / Suckable

05 Chewable / Suckable

06 Chewable / Suckable

07 Chewable / Suckable

08 Chewable / Suckable

09 Clinical Supply

10 Clinical Supply

11 Clinical Supply

12 Clinical Supply

13 Clinical Supply

14 Coated

15 Coated

16 Coated

17 Coated

18 Coated

19 Coated

20 Coated

21 Coated

22 Coated

23 Coated

24 Controlled / Immediate / Modified Release

25 Controlled / Immediate / Modified Release

26 Controlled / Immediate / Modified Release

27 Controlled / Immediate / Modified Release

28 Controlled / Immediate / Modified Release

29 Controlled / Immediate / Modified Release

30 Controlled / Immediate / Modified Release

31 Controlled / Immediate / Modified Release

32 Controlled / Immediate / Modified Release

33 Controlled / Immediate / Modified Release

34 Controlled / Immediate / Modified Release

35 Controlled / Immediate / Modified Release

36 Controlled / Immediate / Modified Release

37 Controlled / Immediate / Modified Release

38 Controlled / Immediate / Modified Release

39 Controlled Substance

40 Controlled Substance

41 Controlled Substance

42 Controlled Substance

43 Controlled Substance

44 Controlled Substance

45 Effervescent

46 Effervescent

47 Effervescent

48 Effervescent

49 Effervescent

50 Extended Release

51 Extended Release

52 Extended Release

53 Fast Disintegrating

54 Fast Disintegrating

55 Fast Disintegrating

56 High Potency APIs (HPAPIs)

57 High Potency APIs (HPAPIs)

58 High Potency APIs (HPAPIs)

59 High Potency APIs (HPAPIs)

60 High Potency APIs (HPAPIs)

61 High Potency APIs (HPAPIs)

62 High Potency APIs (HPAPIs)

63 High Potency APIs (HPAPIs)

64 Modified Release

65 Modified Release

66 Modified Release

67 Orally Disintegrating Tablets (ODTs)

68 Orally Disintegrating Tablets (ODTs)

69 Orally Disintegrating Tablets (ODTs)

70 Orally Disintegrating Tablets (ODTs)

71 Orodispersible

72 Orodispersible

73 Orodispersible

74 Orodispersible

75 Orodispersible

76 Overview

77 Overview

78 Overview

79 Overview

80 Overview

81 Overview

82 Overview

83 Overview

84 Overview

85 Overview

86 Overview

87 Overview

88 Overview

89 Overview

90 Overview

91 Overview

92 Overview

93 Overview

94 Overview

95 Overview

96 Overview

97 Overview

98 Overview

99 Steroid / Hormone

100 Steroid / Hormone

101 Steroid / Hormone

102 Sustained Release

103 Sustained Release

104 Sustained Release

105 Sustained Release

106 Sustained Release

filter

01 AJES Pharmaceuticals, LLC

02 ANFARM HELLAS S.A.

03 AbbVie Contract Manufacturing

04 Adare Pharma Solutions

05 Appco Pharmaceutical Corp

06 Athena Pharmaceutiques

07 Aurigene Pharmaceutical Services

08 Avara Pharmaceutical Services

09 Axxelent Pharma Science

10 BILCARE GCS

11 Bioindustria L.I.M. Spa

12 Biological E

13 Biophore India Pharmaceuticals Pvt Ltd

14 Bioplus Life Sciences

15 Bliss Gvs Pharma Ltd

16 Bora Pharmaceuticals

17 Brooks laboratories Limited

18 Catalent Pharma Solutions

19 Chanelle Medical

20 Delorbis Pharmaceuticals

21 Delpharm Group

22 Douglas CDMO

23 Ethypharm

24 Eurofins CDMO

25 Famar

26 Farbe Firma

27 Fareva

28 Fermion Oy

29 Flagship Biotech International Pvt. Ltd

30 Fresenius Kabi Austria

31 GALIEN LPS

32 Gensenta Pharmaceuticals

33 Glatt Pharmaceutical Services

34 Gracure Pharmaceuticals Limited

35 HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD.

36 ICE Pharma

37 Innopharmax

38 JGL d.d

39 JSC Olainfarm

40 Juniper Pharmaceuticals, Inc

41 LGM Pharma

42 Laboratoires Galéniques Vernin

43 Lecifarma

44 Madras Pharmaceuticals

45 Mikart

46 Mission | CDMO

47 Mithra CDMO

48 Nanjing Dorra Pharmaceutical Technology Co.,Ltd

49 ORIT LABS LLC

50 One Pharma

51 Orchid Pharma

52 Orofino Pharmaceuticals Group

53 PENMIX LTD.

54 PHARMEAL LABORATOIRES

55 PSR Pharma Science and Research

56 Pfizer CentreOne

57 Pierre Fabre

58 Piramal Pharma Solutions

59 Polfa Tarchomin

60 Prague Scientific

61 Priyans Drugs

62 Quotient Sciences

63 R-Pharm Germany GmbH

64 Recipharm AB

65 Renejix

66 Ropack Inc

67 S.C. Rompharm Company SRL

68 Saneca Pharmaceuticals

69 Santa S.A

70 Sharp

71 Sirio Pharma Co. Ltd

72 Skyepharma

73 Societal CDMO

74 Sofarimex

75 Temad Co

76 Tianjin Hankang Pharmaceutical Biotechnology

77 TriRx Pharmaceutical Services

78 Unique Biotech Limited

79 WellSpring Consumer Healthcare

filter

01 Austria

02 Belgium

03 China

04 China

05 Croatia

06 Cyprus

07 Czech Republic

08 Finland

09 France

10 France

11 France

12 France

13 Germany

14 Greece

15 Greece

16 Greece

17 India

18 India

19 India

20 Iran

21 Ireland

22 Italy

23 Italy

24 Latvia

25 Luxembourg

26 New Zealand

27 New Zealand

28 Poland

29 Portugal

30 Romania

31 Singapore

32 Slovakia

33 South Korea

34 Sweden

35 Taiwan

36 Taiwan

37 Turkey

38 U.S.A

39 U.S.A

40 U.S.A

41 U.S.A

42 U.S.A

43 U.S.A

44 U.S.A

45 U.S.A

46 U.S.A

47 United Kingdom

List of Learn MoreList of #LearnMore
Close
4

Overview of oral solid dose (OSD) dosage manufacturing, specifically film coated tablets, complex modified release tablets & controlled substances.

Q1. Tablets, what are they and what are the different types available in the pharmaceutical industry?

Pharmaceutical tablets are solid oral dosage forms prepared by compressing a drug (API) with or without diluents. Tablets function as unit doses that deliver the desired quantity of active pharmaceutical ingredients (API) to the end consumer with unparalleled accuracy. 

There are various dosage forms including liquids, sprays, injectables, creams, suppositories, etc. However, the preferred dosage form by a large margin, remains to be oral solid dose (OSD) dosage forms. Commercial drug product manufacturing trends show that oral solid dose (OSD) dosage forms continue to play a major role in the pharmaceutical contract manufacturing and CDMO industry, representing about 70% of the market. 

Oral solid dosage outsourcing trends further reveal that despite the increasing types of biologics, oral solid forms such as tablets & capsules remain dominant in the commercial market. The ease of administration, identification, and relatively better taste assert pharmaceutical oral solid dosage forms as one of the leading modes of drug administration.

Pharmaceutical solid oral dosage forms are preferred formulations for drug delivery. Tablets have the greatest dose precision, lowest content variability, lowest cost, and various other favorable qualities that make them a desired choice amongst pharma CMOs and CDMOs offering formulation development services (contract development services).

 

Furthermore, tablets offer flexibility as oral formulations and are available as the following types (amongst others):

- Film coated tablets

- Enteric coated tablets

- Buccal tablets

- Extended release tablets

- Complex modified release tablets

- Sustained release tablets

- Effervescent tablets 

- Chewable tablets 

- Compressed tablets 

- Sugar-coated tablets

Q2. How are tablets formulated and what are the manufacturing aspects of film coated tablets?

Tablet formulation development and manufacturing is a stylized process. Each Pharma CMO and CDMO (contract development and manufacturing organization) uses their own pharmaceutical formulation development and manufacturing methodology. Some use the systematic design of experiments (DOE) approach, some test one variable at a time, and many use a combination of the two. 

 

The pharmaceutical formulation development and manufacturing of tablets is completed in the following steps:

Step 1. Preformulation Studies: Preformulation is the stage of development in the pharmaceutical industry, during which physicochemical properties of drug substances are characterized and established. 

This could provide important information for formulation design or anticipate the needs for molecular modifications. Every drug has intrinsic chemical and physical properties which need to be considered before the formulation development and manufacturing of pharmaceutical drug products such as film coated drug products.

Step 2. Dispensing: The first step in tablet development and formulation, after preformulation studies have been conducted and appropriate oral formulations have been chosen, is called dispensing. Dispensing involves weighing all the ingredients in tablets accurately to ensure desired API & excipient amounts in the tablet formulations. 

Step 3. Sizing: The second step in tablet formulation development is known as sizing. During sizing the active ingredients and pharmaceutical excipients used in tablet formulations are broken down to a finely divided forms, to augment flow properties and enable easier mixing of ingredients.

Step 4. Powder Blending: Powder blending uses cutting edge technologies to mix powders and achieve homogeneous mixtures. This step of tablet development and formulation gives blend uniformity and distributes lubricants evenly in the resulting powdered mixture. 

Step 5. Granulation: Most fine pharmaceutical compounds require the formulation development process known as granulation, offered by pharmaceutical CDMOs to improve flow properties and processing properties prior to tableting. Granulation can be divided into two types: dry granulation and wet granulation. 

Step 6. Drying & Dry Screening: If the wet granulation route of tablet formulation development is used in the previous step, then it is followed by drying and dry screening. Dry screening in tablet development refers to passing the dried granules through a mesh screen to undergo compression. 

Step 7. Tablet Compression: The process of tablet compression involves the rearrangement of particles to eliminate voids and create compact dosage forms. The term “direct compression” is defined as the drug product formulation development process in which powdered mixtures of APIs and suitable excipients are directly compressed to form a tablet. 

Direct compression (DC) is by far the simplest means of tablet formulation development and commercial manufacturing, as it only requires the active pharmaceutical ingredient (API) to be properly blended with appropriate excipients before compression. Direct compression further reduces costs, reduces formulation steps, and accelerates time to progress to commercial marketing. Direct compression is thus one of the preferred methods for formulating tableted oral solid dosage forms. 

Step 8. Coating: Tablets are coated to achieve taste masking of bitter drugs and unpleasant odors associated with the pharmaceutical oral formulations. During the pharmaceutical development of film coated drug products, controlled release formulations, modified release drug products (modified release tablets), etc. coatings can change release profiles of the oral solid dose (OSD) dosage forms. 

 

Complex modified release tablets can be formulated using coatings. Coating is thus an imperative product design and development service required to go from drug product development to commercial manufacturing of modified release formulations e.g. sustained release tablets.

After direct compression, tablets can be coated in various ways to achieve different formulations. Film coating is a common step in modified release tablet manufacturing that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilization strategy and to modify or delay drug release of film coated drug products and sustained release tablets.

Therefore, the drug product development & commercial manufacturing aspects kept in mind during the production of film coated drug products (film coated tablets) include the shape, size, stability, and color of the dosage form, as well as the desired release profile of the tablets. 

Q3. What are complex modified release tablets? What advantages do they offer over other solid oral dosage forms?

Drug products are often classified into typical or complex formulations, complex drugs include products with complex active ingredients, complex routes of drug delivery, or complex dosage forms such as controlled release formulations.

If we look at CDMOs (contract development and manufacturing organizations) and pharmaceutical contract manufacturing for oral formulations, focusing on classic and complex oral solid dosage forms (OSD), it encompasses powders, granules, tablets, including press coated tablets and multi-layer tablets, and capsules amongst a variety of other oral solid controlled release formulations. 

 

Oral controlled release drug delivery products are further differentiated on the basis of their timed release profiles into the following types: 

1. Immediate Release

An oral solid dosage form with an instant release profile expels the active ingredient immediately after the drug product is swallowed and reaches the stomach.

2. Sustained Release 

In sustained release there is a sustained release drug delivery of the drug product at a predetermined rate by maintaining a constant drug level for specific periods of time e.g. extended release tablets.

3. Controlled Release 

Controlled release formulations are released into the body in specified amounts over a specified period of time. The controlled-release drug delivery system is designed to release the active pharmaceutical ingredient gradually over the day. Modified release tablet manufacturing is achieved via controlled drug release methodologies. 

 

Controlled release formulations employ controlled delivery expertise in drug product development and controlled release drug delivery technologies, in order to develop a controlled release tablet which adjusts API intake by expelling the desired therapeutic agents to the right part of the gastrointestinal system at the right time, for long periods in the body.

Controlled release dosage forms (extended release tablets), falling under modified release dosage forms , have a modification in their release mechanism, which is developed by altering drug absorption or the site of drug release in order to achieve predetermined clinical objectives. The modified release tablet manufacturing is achieved via controlled drug delivery methods, hence, complex modified release tablets have altered release profiles which can slow down or speed up the release of drugs as compared to conventional pharmaceutical solid oral dosage forms

Modified release tablet manufacturing is achieved via controlled drug release methods, involving both delayed and sustained release mechanisms of action for oral administration. These delivery mechanisms alter the timing or rate of release of active pharmaceutical ingredients to successfully modify the expulsion of poorly water-soluble drugs in the body. 

 

Complex modified release tablets offer numerous advantages over traditional oral formulations, including:

- Tailoring of drug release rates

- Protection of fragile drugs

- Reduction in blood level fluctuations

- Protection against dose dumping

- Increased patient comfort and compliance

- Bioavailability enhancement

- Improved solubility 

- Attenuation of adverse effects 

Q4. What are modified release technologies?

Oral controlled release technologies have been in existence since the early 60’s and have gone through a plethora of modifications and advances over the years. Controlled release technologies encompass modified release technologies and enable the production of modified release drug products e.g. modified release tablets. Some of these modified release technologies are listed below.

Film coating: Modified-release (or functional) film coatings are used when drug release characteristics need to be modified. Modified release tablet film coatings may be further categorized as either delayed-release (e.g. gastro-resistant/ enteric coating) or extended-release coatings.

Multiparticulate technology: The Multiple-Unit Pellet System (MUPS) is a multiparticulate formulation system that has become an important and successful dosage form for immediate or modified drug release. These multiple unit systems allow complex modified release of drugs. The MUPS manufacturing process consists of 2 steps: (1) Pellets manufacturing and (2) Tablet containing pellet formulation. This equips them with the advantages of both tablets and pellets in one dosage form

Bi-layer tablet: Bilayer tablet technology helps in separating the incompatible substances in which one layer is immediate release as loading dose and second layer is controlled/sustained release as maintenance dose. Two incompatible drugs can also be formulated into a bilayer tablet by adding an inert intermediate layer.

Matrix technology: Today, most time-release drugs are formulated so that the active ingredient is embedded in a matrix of insoluble substance(s) (e.g., modified ethyl cellulose or acrylic polymers) such that body fluids pass through the matrix dissolving the drug which then must find its way out through the holes in the matrix. In some modified release formulations, such as modified release tablets, the drug dissolves into the matrix, allowing the drug to exit through the outer surface.

Q5. How does scale-up (technology transfer) occur from development to commercial manufacturing of tablets containing controlled substance drug products?

A controlled substance/controlled drug is a chemical or drug whose development and distribution is tightly regulated by the government. Therefore, controlled substances can refer to illicit drugs like stimulants and opioids or to prescription medications like morphine, valium, and Ritalin. Manufacturing controlled drugs must be closely monitored, and the process must be implemented on a global scale.

The DEA controlled substance or DEA-controlled compound market is growing rapidly, driven by trends in oncology and increased access to treatment for neurological disorders. Contract drug manufacturing for DEA controlled substances offer solutions for the safe and secure development and manufacture of DEA controlled substances or DEA-controlled compounds.

Controlled substance manufacturing and use of controlled drugs is restricted to avoid drug abuse and addictions. Controlled substance manufacturing offered under contract drug manufacturing is similar to other dosage forms going from drug product development to commercialization with the help of scale up and technology transfer services.

 

- Scale up is generally defined as the process of increasing batch sizes. In process scale-up, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacturing that affects the orderly transition from laboratory to routine processing in a full-scale pharmaceutical contract manufacturing facility. It must include a close examination of the formula to determine its ability to withstand an aggregation of batch-scale and process modification concerns.

QbD: In pharmaceutical product design, scale up may be accompanied by quality by design (QbD) studies. QbD approaches can be used to validate analytical methodology, assess variability, perform method optimization of sample collection time intervals, and provide other information in a small number of subjects before proceeding with a full-scale bioequivalence study prior to commercial drug product manufacturing.

- Technology transfer is a process to transfer information and technologies necessary for contract drug manufacturing of quality drug products consistently, or it’s the process of taking an invention from its inception in a laboratory to commercial drug product manufacturing. This stage of development has its share of complex transfer requirements and pharmaceutical product design complexities. CDMOs for formulation tech transfer are involved in creating standard operating procedures, for master batches that demonstrate perfect scale-up working conditions in kilo labs, which are then replicated at a large-scale after cGMP requirements compliance is achieved. 

CDMOs (contract development and manufacturing organizations) offering controlled drug formulation, development, and delivery services, include scale-up and tech transfer within their expertise. As a result of these activities, a milligram preparative method becomes a multi kg process, without impacting the quality or the performance of the controlled substance drug products.

First
Last

Post Enquiry
POST ENQUIRY